Abstract
Objectives
To evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, in addition to retention rate and data completeness. An ancillary aim was to describe within-group changes in the secondary outcome measures (patient-reported and performance-based).
Design
A single-centre, three-armed, randomised controlled feasibility trial with a parallel design, with follow-up after 3 and 6 months.
Setting
Participants were recruited from the outpatient clinic at Oslo University Hospital.
Participants
Patients with lateral epicondylalgia, commonly known as tennis elbow.
Interventions
Participants were randomised in a 1:1:1 ratio to heavy slow resistance training, radial extracorporeal shock wave therapy or information and advice.
Main outcome measures
Feasibility was assessed according to a priori criteria for success.
Results
In total, 89 patients were screened for eligibility, and 69 (78%) patients were eligible for randomisation. 60 (92%) participants were randomised which gave a recruitment rate of 3.4 per month (against an a priori success cut-off of 3.75). The participants rated all the interventions as acceptable and comprehensive. Only 6 of 19 (32%) did comply with heavy slow resistance training. Retention rate and completeness of data were successful at 3 months. At 6 months, the retention rate was below the criteria for success. Patient-reported and performance-based outcomes improved in all groups.
Conclusion
The current study shows that the process of recruitment and the retention rate at follow-up can be feasible with minor amendments. Participants had low compliance with heavy slow resistance training mainly due to pain aggravation, which suggests that this intervention was not suitable for patients with tennis elbow. Shock wave therapy and information and advice should be investigated further in a full-scale randomised controlled trial including sham shock wave therapy.
Trial registration number
Keywords: Elbow Tendinopathy, Feasibility Studies, Physical Therapy Modalities, Randomized Controlled Trial, SPORTS MEDICINE, Tennis Elbow
STRENGTHS AND LIMITATIONS OF THIS STUDY.
Patients participated in developing this study.
The heavy slow resistance training protocol is reported using the Consensus on Exercise Reporting Template.
The study recruited participants with pragmatic exclusion criteria that reflect the real-world patient in secondary care.
The feasibility of the blinding was not evaluated.
Background
Tennis elbow, also known as lateral epicondylalgia, is a common musculoskeletal condition with a prevalence of 1.3%, incidence 3.4 (95% CI, 3.3 to 3.5) per 1000 and a recurrence rate within 2 years of 8.5%.1 2 Tennis elbow is a painful condition that impacts quality of life. It causes functional disability with high costs due to productivity loss, healthcare use and absence from work.3,5 Although most cases of tennis elbow are self-limited, 66% report not fully recovered after 1 year and 54% after 2 years.6,8
Exercises are considered the first-line treatment for tennis elbow, and various physiotherapy treatments as well as radial extracorporeal shock wave therapy are often offered.9 However, there is no common agreement on the best management for tennis elbow. Recent systematic reviews report the beneficial effects of exercises for tennis elbow, but the lack of detailed descriptions of exercise components makes recommendations for the optimal exercise protocol difficult.10 11 Previous research on heavy slow resistance training for achilles and patellar tendinopathy reports clinical improvements, high patient satisfaction, good compliance rates and structural changes.12 13 To the best of our knowledge, there are no published trials testing heavy slow resistance training with dumbbells for tennis elbow.
Previous studies suggest that radial extracorporeal shock wave therapy is effective in pain reduction and grip strength recovery for tennis elbow, but the evidence is sparse and inconsistent.14 15 Systematic reviews and meta-analyses of shock wave therapy on tennis elbow report low to moderate evidence of no benefit to sham shock wave therapy. More rigorously designed, large-sample, high-quality trials investigating shock wave therapy for tennis elbow are recommended to guide future clinical practice.16 17
Despite the pronounced use of physiotherapy, few studies with low risk of bias exist.1011 15 18,20 One way to reduce bias and improve the quality of clinical trials is to work out the uncertainties of the trial design beforehand. A feasibility study is designed to inform about the process and management, help us understand resource requirements and to advance scientific inquiry. This may prevent research waste.21 The primary aim was to conduct a randomised controlled feasibility trial with heavy slow resistance training, radial extracorporeal shock wave therapy and information and advice in patients with tennis elbow. Specific aims were to evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, as well as retention rate and data completeness at follow-up. An ancillary aim was to describe within-group changes from baseline to follow-up in secondary outcome measures.
Methods
The current study was a single-centre, three-armed, randomised controlled feasibility trial with a parallel design, allocated 1:1:1, with follow-up after 3 and 6 months. Participants also took part in a study testing the psychometric properties of outcome measures. Hence, the actual enrolment on ClinicalTrials.gov is registered as 100 participants, 60 participants included in the feasibility study and another 40 participants only included to test the psychometric properties of the outcome measures. The final data collection was in December 2023.
Patient and public involvement
User involvement was embedded through the Patient Panel, consisting of user representatives with various musculoskeletal disorders, established at the Research and Communication Unit for Musculoskeletal Health at Oslo University Hospital. The Patient Panel participated in developing the study information and materials. The intervention protocols were presented to the Patient Panel, and adjustments were made accordingly.
Study design
The trial was designed as a randomised controlled feasibility trial and reported according to the 26-item checklist from The Consolidated Standards of Reporting Trials 2010 statement: extension to randomised pilot and feasibility trials.22 Approximately one week after inclusion, the participants were randomised by a co-investigator. The randomisation sequence was computer-generated with blocks of variable sizes (range 3–9), which were unknown to the treating physiotherapist. Data were collected on paper at an outpatient clinic at baseline, after the group allocation and after 3 months. Six months follow-up data were sent and collected by mail. If participants did not respond, they were followed up by phone and reminded to respond once. One postgraduate physiotherapist included, treated and followed up participants. Due to the nature of the interventions, neither the physiotherapist nor the participants could be blinded. Since this is not an effectiveness trial, crossover from the information and advice group was possible after the 3-month follow-up.
Study population
Participants were recruited from the outpatient clinic at the Department of Physical Medicine and Rehabilitation at Oslo University Hospital. Medical doctors screened participants prior to eligibility, as part of normal clinical practice at the outpatient clinic. Eligible participants were enrolled to the study after being assessed by the physiotherapist.
The inclusion criteria were
≥18 years old.
Two out of five clinical provocation tests had to be provocative of the symptoms on the lateral side of the elbow.23 24 (a) Pain on palpation, (b) pain on resisted wrist extension (Cozen test), (c) pain during power grip, (d) pain on resisted third finger extension (Maudsley test) and (e) pain on passive elbow extension combined with wrist palmar flexion (Mills test).
The exclusion criteria were
Insufficient language skills to participate.
Contraindications to shock wave therapy (ie, pregnancy, coagulation disturbance, usage of anticoagulants, connective tissue disease, epilepsy or use of pacemaker).
Any suspicion of other serious illness.
All participants provided written informed consent before inclusion.
Baseline assessments
To describe the baseline demographics, participants filled out a set of sociodemographic variables such as age, sex, height, weight, education, works status and type of work. They also reported pain duration, usage of pain medication, previous treatments and number of pain sites.25
Interventions
All groups received the same written and oral information about aetiology, pathogenesis, treatment options and the prognosis. Participants were informed that it is safe to use the arm despite pain and that pain does not equal harm. The importance of using the arm to regain and maintain function was emphasised. Load management with a gradual increase in load within tolerable pain was recommended.
Heavy slow resistance training
The participants received a written protocol on how to perform and progress the exercises based on previous protocols on heavy slow resistance training.12 13 26 A postgraduate physiotherapist instructed individually face-to-face, a 12-week home training programme (ie, totally 36 training sessions) consisting of two exercises. One exercise addressed wrist extension and flexion, and the other pronation and supination of the forearm holding a dumbbell. Details are reported after Consensus on Exercise Reporting Template (table 1).27 Participants were also instructed to stretch their extensor muscles with a straight elbow, pronated and palmar flexed wrist, three times a day, three sets for 30 s. Appointments for supervision with a physiotherapist during the intervention period were voluntary. Participants were offered supervision up to once per week and could choose between digital or physical consultations. They were provided with a workout diary and urged to report on fulfilled sessions. No restrictions were given, but a plan of action was provided if there was aggravation of pain from the training (table 1).
Table 1. Description of heavy slow resistance training protocol.
| 1. Load magnitude and progression | A dumbbell as heavy as possible within the given repetitions for the current week. |
| 2. (Week) number of repetitions | (1): 15 reps, (2–3): 12 reps, (4–5): 10 reps, (6–8): 8 reps, (9–12): 6 reps |
| 3. Number of sets | 3 |
| 4. Rest between sets | 2–3 min. |
| 5. Number of exercises | 2 |
| 6. Duration of experimental period | 12 weeks |
| 7. Temporal distribution of the contraction modes per repetition | 4 s concentric4 s eccentric |
| 8. Rest in-between repetitions | No |
| 9. Range of motion | Full range of motion |
| 10. Training frequency | 3 times a week, with minimum 48 hours recovery time in-between. |
| 11. Anatomical definition of exercise (exercise performance) | In both exercises, the patient sits resting their forearm on a table with a flexed elbow, holding a dumbbell outside the end of the table top. Exercise 1 starts with the wrist pronated and flexed, the patient performs a wrist extension movement while maintaining pronation. In exercise 2, the patient starts pronated and performs a supination-pronation movement while maintaining a neutral flexion/extension. |
| 12. Action if pain | Pain while training is allowed. If the pain after the exercises was not tolerable, affected sleep or lasted into the next training session, they were instructed to decrease their weight the next training session. |
Radial extracorporeal shock wave therapy
Participants received written and oral information about the treatment. Shock wave therapy was given using an EMS-DolorClast with a Swiss DolorClast Evo blue handpiece with a 15 mm applicator able to deliver up to 0.18 mJ/mm2. A treatment protocol was followed as recommended by the manufacturer (EMS DolorClast). Participants had three sessions with approximately 1 week a part, receiving 2000 impulses at 10 Hz, with a low energy treatment between 1.5 and 3 BAR. To maximise potential outcomes, the treatment was given over the area of maximal pain during palpation of the lateral epicondyle. No restrictions were given after the treatment.
Information and advice
Participants received a single individual face-to-face session with a postgraduate physiotherapist providing information and advice according to the protocol. The session lasted up to 45 min. Included in this session was the same written and oral information as all participants. They were asked to specify their primary challenges and set their own recovery goals. Pacing and load management to accomplish their goals were discussed. Participants were asked about their pain-believes and behaviour. They were also assured about the robustness of the elbow despite the pain. The natural course of the condition and the good prognosis over time were emphasised. No restrictions were given, and participants were encouraged to use their arms as normal as possible regardless of pain.
Feasibility outcomes
To evaluate the feasibility of the trial, a priori criteria for success were determined (table 2). The first objective was to measure the process of recruitment. Second, the appointment adherence, intervention compliance, acceptability and comprehensiveness. Adherence was measured in attendance to scheduled physiotherapy appointments. The compliance was measured in a number of completed training sessions. The intervention acceptability and comprehensibility were measured directly after receiving the first session and at the 3-month follow-up. It was scored on a 19-point Likert scale from −9 (I do not accept/understand my treatment) to +9 (I completely accept/understand my treatment). The third objective was to measure the retention rate and completeness of data at 3 and 6 months. Results were interpreted accordingly: (a) go–proceed with Randomised Controlled Trial (RCT), (b) amend–proceed with changes and (c) stop–do not proceed unless changes are possible.21
Table 2. Primary outcomes with a priori criteria for success and results.
| Primary outcomes | Criteria for success | Result |
| The process of recruitment | ||
| Eligible for randomisation | >75% | 69/89 (78%) |
| Willingness to be randomised | >90% | 60/65 (92%) |
| Recruitment rate (participants per month) | 3.75 | 3.37 |
| Appointment adherence | ||
| Scheduled appointments carried out | ||
| Training | 90% | 38/42 (90%) |
| Shock wave therapy | 90% | 60/60 (100%) |
| Intervention compliance, acceptability and comprehensiveness | ||
| Participants performed ≥30/36 training sessions within 12 weeks | – | 6/19 (32%) |
| Participants within each intervention group rating ‘acceptable’ (≥+3) at baseline | ||
| Information and advice | ≥10/20 | 16/20 (80%) |
| Training | ≥10/20 | 19/20 (95%) |
| Shock wave therapy | ≥10/20 | 20/20 (100%) |
| Participants within each intervention group rating ‘acceptable’ (≥+3) at 3 months follow-up | ||
| Information and advice | ≥10/20 | 11/18 (61%) |
| Training | ≥10/20 | 13/19 (68%) |
| Shock wave therapy | ≥10/20 | 20/20 (100%) |
| Participants within each intervention group rating ‘understandable’ (≥+3) at baseline | ||
| Information and advice | ≥10/20 | 18/20 (90%) |
| Training | ≥10/20 | 20/20 (100%) |
| Shock wave therapy | ≥10/20 | 20/20 (100%) |
| Participants within each intervention group rating ‘understandable’ (≥+3) at 3 months follow-up | ||
| Information and advice | ≥10/20 | 14/18 (78%) |
| Training | ≥10/20 | 18/19 (95%) |
| Shock wave therapy | ≥10/20 | 20/20 (100%) |
| Outcome measures | ||
| Retention rate at 3 months | >75% | 58/60 (97%) |
| Retention rate at 6 months | >75% | 41/60 (68%) |
| Completeness of data at baseline | ||
| Patient-rated tennis elbow evaluation | >75% | 60/60 (100%) |
| Quick-DASH | >75% | 60/60 (100%) |
| EQ-5D-5L | >75% | 60/60 (100%) |
| Pain-free grip strength | >75% | 60/60 (100%) |
| Completeness of data at 3 months | ||
| Patient-rated tennis elbow evaluation | >75% | 57/58 (98%) |
| Quick-DASH | >75% | 58/58 (100%) |
| EQ-5D-5L | >75% | 58/58 (100%) |
| Pain-free grip strength | >75% | 58/58 (100%) |
| Completeness of data at 6 months | ||
| Patient-rated tennis elbow evaluation | >75% | 41/41 (100%) |
| Quick-DASH | >75% | 41/41 (100%) |
| EQ-5D-5L | >75% | 41/41 (100%) |
EQ-5D-5LEuroQol-5 Dimension-5 levelsQuick DASHQuick Disability of the Arm, Shoulder and Hand
Secondary outcome measures
Participants filled in the Patient-rated tennis elbow evaluation,28 29 the Quick-Disabilities of the Arm, Shoulder and Hand (Quick-DASH),30,33 the 5-Level EuroQol-5D (EQ-5D-5L),34 35 a Numeric Rating Scale Pain (NRS-P) now and a 13-point Global Rating Of Change (GROC). Additionally, pain-free grip strength (kg) was measured and pain on gripping (0: no pain to 10: worst imaginable pain) was reported.36 The patient-rated tennis elbow evaluation consists of two subscales: (a) pain, which is scored from 0 (no pain) to 50 (worst imaginable) and (b) function, which is scored from 0 (no difficulty) to 50 (unable to do). A total score of 100 on the patient-rated tennis elbow evaluation can be computed, a higher score equals more disability. The Quick-DASH ranges from 0 to 100, a higher score indicates more disability. EQ-5D-5L is measured in five levels from 1 (no problems) to 5 (extreme problems). Results can also be presented as an index value from −0.59 to 1, where 1 represents the best possible health state. The EQ visual analogue scale is rated from 0 (worst imaginable health state) to 100 (best imaginable health state). NRS-P was scored from 0 (no pain) to 10 (worst imaginable pain). GROC was measured from −6 (maximal worsening) to +6 (completely recovered).
Sample size
As this was a feasibility study, a formal sample size calculation was not performed. Based on the total access of tennis elbow patients at the outpatient clinic in previous years, a total sample of 60 participants included at a rate of 3.75 participants per month was considered to be realistic. Hence we estimated an inclusion period of 16 months of inclusion, which would give the study a realistic impression of the process of recruitment. The sample size of 20 in each intervention arm was estimated as sufficient to capture the diversity in compliance, acceptability, comprehensiveness, adverse events and dropouts.
Statistical analysis
Statistical analysis was undertaken using IBM SPSS Statistics for Windows (V.29.0 Armonk, New York, USA: IBM Corp.) Descriptive statistics were used to assess the feasibility criteria and the patient-reported outcomes measures (secondary outcomes). Mean and SD, median and IQR, and frequency (%) were reported according to the scale of the data.
Results
60 participants were included from August 2021 to February 2023. The final follow-up data collection for the study took place in September 2023. Participants were middle-aged women (68%) with a mean age of 47.8 (SD 9.3) years and a symptom duration of more than 3 months (90%). They were mainly university-educated (67%) and worked full or part time (63%). Most of the participants had previously received exercises for the affected elbow (67%) (table 3).
Table 3. Baseline characteristics of participants.
| Characteristics | All (n=60) | Shock wave (n=20) | Training (n=20) | Info and advice (n=20) |
| Female gender, n (%) | 41 (68) | 14 (70) | 12 (60) | 15 (75) |
| Age, mean (SD) | 47.8 (9.3) | 49.2 (10.5) | 46.3 (9.6) | 47.8 (8.5) |
| BMI, mean (SD) | 25.6 (3.9) | 25.8 (3.7) | 27 (4.6) | 24 (2.6) |
| Norwegian first language, n (%) | 43 (71) | 15 (75) | 15 (75) | 13 (65) |
| Work, n (%) | ||||
| Full-time | 28 (46.5) | 6 (30) | 11 (55) | 11 (55) |
| Part-time | 10 (16.5) | 5 (25) | 4 (20) | 1 (5) |
| On sick leave | 18 (30) | 6 (30) | 4 (20) | 8 (40) |
| Other social welfare benefits | 4 (7) | 3 (15) | 1 (5) | – |
| Type of work*, n (%) | ||||
| Computer | 39 (65) | 9 (45) | 15 (75) | 15 (75) |
| Sitting still | 35 (58) | 8 (40) | 13 (65) | 14 (70) |
| Repeating movements | 22 (37) | 8 (40) | 6 (30) | 8 (40) |
| Large amount of lifting | 19 (32) | 6 (30) | 6 (30) | 7 (35) |
| Large amount of walking | 12 (20) | 3 (15) | 7 (25) | 2 (10) |
| Education, n (%) | ||||
| Primary school | 2 (3) | 2 (10) | – | – |
| College | 18 (30) | 6 (30) | 7 (35) | 5 (25) |
| University | 40 (67) | 12 (60) | 13 (65) | 15 (75) |
| Symptom duration, n (%) | ||||
| 1–3 months | 6 (10) | 1 (5) | 3 (15) | 2 (10) |
| 4–12 months | 32 (53) | 13 (65) | 6 (30) | 13 (65) |
| >12 months | 22 (37) | 6 (30) | 11 (55) | 5 (25) |
| Pain medication, n (%) | ||||
| 4–7 days a week | 12 (20) | 4 (20) | 5 (25) | 3 (15) |
| 1–3 days a week | 12 (20) | 4 (20) | 4 (20) | 4 (20) |
| 0–3 days a month | 33 (55) | 12 (60) | 9 (45) | 12 (60) |
| Never | 3 (5) | – | 2 (10) | 1 (5) |
| Previous treatment*, n (%) | ||||
| Shock wave therapy | 11 (18) | 1 (5) | 6 (30) | 4 (20) |
| Exercises | 40 (67) | 12 (60) | 14 (70) | 14 (70) |
| Bilateral elbow pain, n (%) | 12 (20) | 2 (10) | 7 (35) | 3 (15) |
| Pain in dominant arm/hand, n (%) | 54 (90) | 18 (90) | 19 (95) | 17 (85) |
| Number of pain sites: 0–10, median (IQR) | 2 (2–4) | 2 (1–4) | 2 (2–4) | 3 (1–5) |
| Ipsilateral shoulder pain (%) | 29 (48) | 8 (40) | 10 (50) | 11 (55) |
| EQ-5D-5L, median (IQR) | ||||
| Mobility | 1 (1–2) | 1 (1–2) | 1 (1–2) | 1 (1–1) |
| Self-care | 2 (1–2) | 1 (1–2) | 1 (1–2) | 2 (1–2) |
| Usual activities | 2 (2–3) | 2 (2–3) | 3 (2–3) | 3 (2–4) |
| Pain/discomfort | 3 (2–4) | 3 (2–3) | 3 (2–4) | 3 (3–4) |
| Anxiety/depression | 1 (1–2) | 1 (1–2) | 2 (1–2) | 1 (1–2) |
| EQ visual analogue scale: 0–100, mean (SD) | 62 (20) | 55.5 (19) | 61.8 (21) | 69 (17) |
| EQ5D Index: −0.59 to 1, mean (SD) | 0.589 (0.172) | 0.620 (0.136) | 0.597 (0.179) | 0.551 (0.197) |
Multiple responses allowed.
BMI, body mass index; EQ-5D-5L, EuroQol-5 Dimension-5 levels
The process of recruitment
A total of 98 patients were registered with tennis elbow at the Department of Physical Medicine and Rehabilitation at Oslo University Hospital between 1 August 2020 and 31 January 2023. 89 patients were screened for eligibility, and 78% were eligible for randomisation (figure 1). Of these, four did not meet the inclusion criteria, and five were not willing to be randomised. Thus, 92% were willing to be randomised which gave a recruitment rate of 3.4 participants per month (table 2). The main reasons for exclusion were the usage of anticoagulants and insufficient Norwegian language skills.
Figure 1. CONSORT flowchart.22 CONSORT, Consolidated Standards of Reporting Trials.
Interventions
All the interventions were above the criteria for success for acceptability and comprehensibility (table 2).
Heavy slow resistance training
The median number for follow-up appointments was 2 (range 0–5). Six participants used the opportunity for digital follow-up (ie, phone or video). The median number of performed self-training sessions within 12 weeks was 26 (range 6–35) of 36 possible. The compliance rate with 30 or more training sessions per participant was 32% (6/19). Eight participants reported increased pain from training as the reason for non-compliance. Five participants reported increased pain from training as an adverse event. 42 appointments for follow-up with the physiotherapist were scheduled among the 20 participants, whereas 38/42 (90%) were undertaken (table 2). Three participants reported seeking other treatment during the 3-month follow-up period. At 6 months, three participants reported seeking other treatments (figure 1).
Radial extracorporeal shock wave therapy
The three shock wave therapy sessions were carried out for all 20 participants (100% adherence) (table 2). Two participants reported increased pain up to 12 hours after treatment. One participant reported seeking other treatment during the 3-month follow-up period. At 6 months, none of the participants reported seeking other treatment (figure 1).
Information and advice
10 participants wanted a crossover treatment after the 3-month follow-up. Of these, six chose shock wave therapy and four training. No adverse events were reported. One participant reported seeking other treatment during the 3-month follow-up period. At 6 months, two participants reported seeking other treatment (figure 1).
Feasibility of outcome measures
At baseline and 3 months follow-up, the outcomes evaluating the retention rate and completeness of data were above the criteria for success (>75%). However, retention rate at 6 months was below the criteria for success with 68% (table 2).
Within-group changes
All groups improved in the patient-reported outcome measures and in the pain-free grip strength from baseline to 3 and 6 months. From baseline to 3 months, all groups were above the minimal detectable change for the patient-rated tennis elbow evaluation and Quick-DASH mean change scores of 8.9 and 11.2, respectively. At 3 months, 66% had improved and 10% were worse on the GROC scale among all participants (table 4).
Table 4. Secondary outcome measures at baseline, 3 and 6 months.
| Scondary outcomes | Scores | |||
| All | Shock wave | Training | Info & advice | |
| Patient-rated tennis elbow evaluation pain: 0–50, mean (SD) | ||||
| Baseline | 24.9 (9.0) | 24.8 (7.6) | 24.6 (10.4) | 25.2 (9.5) |
| 3 months | 13.8 (11.5) | 11.4 (9.6) | 15.9 (14.3) | 14.2 (10.2) |
| 6 months | 9.8 (8.4) | 9.2 (8.8) | 11.9 (11.3) | 8.7 (5.1) |
| Patient-rated tennis elbow evaluation function: 0–50, mean (SD) | ||||
| Baseline | 20.3 (9.4) | 19.0 (7.8) | 18.4 (10.1) | 23.4 (9.8) |
| 3 months | 8.9 (10.0) | 6.8 (8.1) | 9.8 (12.0) | 10.3 (10.0) |
| 6 months | 6.4 (6.9) | 6.1 (7.4) | 8.5 (9.1) | 5 (3.6) |
| Patient-rated tennis elbow evaluation total: 0–100, mean (SD) | ||||
| Baseline | 45.1 (17.1) | 43.8 (13.9) | 43.0 (19.0) | 48.6 (18.2) |
| 3 months | 22.5 (20.9) | 18.1 (17.5) | 25.7 (25.2) | 23.9 (19.7) |
| 6 months | 16.1 (15.1) | 15.3 (15.9) | 20.5 (20.3) | 13.7 (8.6) |
| Quick-DASH: 0–100, mean (SD) | ||||
| Baseline | 43.3 (17.0) | 42 (10.4) | 41.1 (18) | 46.8 (21.4) |
| 3 months | 23.8 (22.1) | 17.5 (17.3) | 27.5 (26.7) | 26.9 (21.2) |
| 6 months | 18.9 (15.6) | 18.0 (15.1) | 24.2 (22.2) | 15.7 (8.3) |
| EQ5D Index: −0.59 to 1, mean (SD) | ||||
| Baseline | 0.589 (0.172) | 0.620 (0.136) | 0.597 (0.179) | 0.551 (0.197) |
| 3 months | 0.721 (0.194) | 0.730 (0.269) | 0.674 (0.270) | 0.761 (0.118) |
| 6 months | 0.771 (0.165) | 0.771 (0.161) | 0.733 (0.232) | 0.800 (0.099) |
| Pain-free grip strength* kg, mean (SD) | ||||
| Baseline | 20.0 (11.0) | 20.2 (9.4) | 23.3 (13.7) | 16.6 (8.7) |
| 3 months | 29.5 (12.3) | 31.7 (9.7) | 31.9 (15.1) | 24.8 (10.8) |
| Pain on gripping: 0–10, median (IQR) | ||||
| Baseline | 5 (2–8) | 4 (1–8) | 5 (2–8) | 6 (4–8) |
| 3 months | 2 (0–5) | 0 (0–4) | 0 (0–7) | 2 (1–6) |
| NRS-P now: 0–10 median (IQR) | ||||
| Baseline | 5 (3–7) | 5 (3–7) | 5 (3–7) | 5 (2–7) |
| 3 months | 2 (0–4) | 1 (1–4) | 2 (0–6) | 2 (1–4) |
| GROC: −6 to +6, n (%) | ||||
| Success at 3 months† | 18/58 (31) | 9/20 (45) | 6/19 (32) | 3/19 (16) |
| Improved at 3 months‡ | 38/58 (66) | 15/20 (75) | 10/19 (53) | 13/19 (68) |
| Worse at 3 months | 6/58 (10) | 1/20 (5) | 4/19 (21) | 1/19 (5) |
Mean of three measures.
A great deal better≥5.
Moderately better≥3.
EQ-5D-5LEuroQol-5 Dimension-5 levelsGROCGlobal Rating of ChangeNRS-PNumeric Rating Scale PainQuick DASHQuick Disability of the Arm, Shoulder and Hand
Discussion
The aim of the study was to test the feasibility of an RCT comparing heavy slow resistance training, radial extracorporeal shock wave therapy and information and advice. The recruitment rate was 10% below the criteria for success. According to our predetermined criteria, all interventions were acceptable and comprehensible, but only 32% complied in the training group. The outcome measures showed a successful retention rate at 3 months, but not at 6 months. The completeness of data was above the criteria for success. The mean patient-reported and performance-based outcomes improved in all groups.
Previous research on exercise therapy for the management of tendinopathy suggests that patients are generally satisfied.37 In the present study, the compliance with training was too low for recommendation of a full-scale RCT aiming to evaluate the effectiveness of heavy slow resistance training. One possible explanation is that 70% of participants in the training group had already tried some kind of exercise without success, suggesting that they had low expectations for the training intervention. The discrepancy between the acceptance rate of 68% of participants at 3 months and the low compliance to training of only 32% indicates that the 80% cut-off for compliance might have been set too high. However, adherence to exercise protocols is usually good and a recent scoping review found that among 97 studies, the median adherence was 82.5% (range: 45.3–100).38 Previous heavy slow resistance training research has reported good compliance and high patient satisfaction, unlike the present study. This research has been carried out on athletes, which represent a highly selected population with regard to exercise.12 13 25% reported increased pain as the reason for not performing the exercises and 21% reported worsening at 3 months. This agrees with Vuvan et al39 reporting that 14% of their exercise group experienced worsening.
The shock wave therapy group had 100% appointment adherence and was the only group without any dropouts, which indicates that this is a feasible intervention in a future study. However, to determine the effectiveness of shock wave therapy in a full-scale RCT, it must be compared with sham shock wave therapy. A systematic review found six studies comparing shock wave therapy to sham shock wave treatment for tennis elbow. Compliance and follow-up rates were high which suggests that both shock wave therapy and sham treatment were feasible.1640,45 Recently, two large RCTs in the Norwegian secondary care successfully completed sham-controlled trials in patients with tendinopathies in the shoulder or in the heel and reported successful masking and low dropouts.46 47 Thus, sham shock wave therapy should also be feasible for a similar population with tennis elbow.
The information and advice group was above the criteria for success for acceptability and comprehensibility. A recent consensus study on optimised physiotherapy for lateral elbow tendinopathy ranked advice and education as the most important part.48 Large RCTs including patients with shoulder pain have successfully carried out similar interventions.49 50 However, half of the included participants in this study wanted to cross over after the 3-month follow-up, thus not satisfied with the intervention alone. This may suggest that the criteria for success were set too low a priori. Patient expectations, contextual factors and communication with the therapist are important for a successful intervention and should be explored further before a full-scale RCT. The current study did not measure changes in the patient’s perception after the information and advice were given. Thus, the interventions effect on opinions and behaviour is unknown.
The current study included mostly participants having a university education, and working on a computer, which is in line with characteristics Sanders et al found in their population-based study.2 Contrarily, most studies report that tennis elbow is more common among blue-collar workers exposed to hand or elbow movements.3 51 52 In agreement with previous research on tennis elbow conducted in the Norwegian primary healthcare, 30% of the participants were on sick leave.4 Health-related quality of life was below the Norwegian population norms at baseline, and about half the study cohort reported light symptoms of anxiety or depression which is in line with the general population.53 Among participants included in the present study, 90% had long-term symptoms (>3 months).23 This suggests that it is feasible to include only participants with long-term symptoms in a future full-scale RCT in the same setting.
Baseline and change scores, for the patient-rated tennis elbow evaluation and Quick-DASH, are comparable to other RCTs on tennis elbow.3954,57 From baseline to 3 months, all groups improved from moderate pain to mild pain according to the patient-rated tennis elbow evaluation pain subscale.58 Although the outcomes favoured the shock wave therapy group, the primary aim of the present study was not to compare improvements in symptoms.
Limitations
The present study discovered discrepancies between acceptance and the compliance rate in the training group, and acceptance and crossover treatment in the information and advice group, which suggests that the a priori criteria for success were set too low.
A traffic light approach was used to evaluate the progression criteria, but the cut-off for amber light was not defined a priori.21 Thus, values below the cut-off were assessed based on empirical data. A recent recommendations for progression criteria endorse the use of the traffic light approach as a way to highlight, and draw attention to problems that have been faced, rather than use it as a firm rule.21 A guidance to decision-making if progression criteria results are below the cut-off could be a hierarchical prioritisation of outcomes based on their importance (eg, potential adverse events, compliance, important stakeholders and resources). Such prioritisation should be done a priori.
A possible reason for the low retention rate at 6 months in our study is that follow-up only being questionnaires sent by postal mail. A physical attendance follow-up could have increased the retention-rate. Preferably, we should have explored this by asking participants why they did not respond to the follow-up questionnaires. Also, not excluding patients who recently have received shockwave treatment, exercises or other treatments might have influenced results. A future full-scale RCT measuring the effectiveness of treatment should try to reduce this. The study recruited participants with pragmatic exclusion criteria that reflect the real-world patient in secondary care, arguably increasing the external validity of the study.
The exercise group did not have mandatory appointments for supervision as we wanted to evaluate the participant’s wishes for supervision, but this may have affected the intervention compliance. Mandatory appointments could have given another outcome, because supervision gives better adherence to exercises.38 Participants who experienced pain could potentially increase compliance if they were assured and guided through the training sessions. More appointments could also lead to better patient-practitioner relationship which is suggested to be an important predictor for adherence.59
There was no blinded assessor, thus the feasibility of the blinding was not evaluated. The participants answered questions about the acceptability and comprehensibility directly to the treating physiotherapist, who also gave the intervention, which might have created observer and reporting bias.
The current study did not evaluate the feasibility of health economics questionnaires, which is an important part of a future full-scale RCT. Health economics questionnaires can be cumbersome to complete, and the lack of these might have led to an overestimation of the completeness of data.
Conclusion
The current study shows that the process of recruitment and the retention rate at follow-up can be feasible with minor amendments. Participants had low compliance with heavy slow resistance training mainly due to pain aggravation, which suggests that this intervention was not suitable for patients with tennis elbow. Shock wave therapy and information and advice should be investigated further in a full-scale randomised controlled trial including sham shock wave therapy.
Acknowledgements
We would like to thank Sophies Minde AS for their funding, Helene Engberg Skaara, Department of Physical Medicine and Rehabilitation, Oslo University Hospital, for facilitating infrastructure to perform the present study. Finally, we would like to thank all the participants who participated in the study.
Footnotes
Funding: Sophies Minde Ortopedi AS (Oslo, Norway), a daughter company of Oslo University Hospital, has financially supported the present study. Sophies Minde AS had no role in the design of the study or collection, analysis or interpretation of the data. Nor did they participate drafting the manuscript.
Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-085916).
Data availability free text: The datasets used and/or analysed during the current study is available from the first author on reasonable request within five years of publication.
Patient consent for publication: Not applicable.
Ethics approval: This study involves human participants and was approved by The Regional committees for medical and healthcare research ethics (REK109547). Participants gave informed consent to participate in the study before taking part.
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Contributor Information
Håkon Sveinall, Email: hasvei@ous-hf.no.
Jens Ivar Brox, Email: j.i.brox@medisin.uio.no.
Kaia B Engebretsen, Email: uxaien@ous-hf.no.
Aasne Fenne Hoksrud, Email: AasneFenne.Hoksrud@olympiatoppen.no.
Cecilie Røe, Email: CEROEE@ous-hf.no.
Marianne Bakke Johnsen, Email: m.b.johnsen@medisin.uio.no.
Data availability statement
Data are available upon reasonable request.
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