Skip to main content
. 2015 May 26;2015(5):CD010664. doi: 10.1002/14651858.CD010664.pub2

Taimela 2000.

Study characteristics
Methods RCT, “randomly assigned into one of the three interventions, the randomization was performed in blocks of three stratified by sex, age, and severity of the disorder based on pain drawing”
Participants 76 patients; mean age ± SD in (I): women 44.0 ± 8.4 years, men 38.8 ± 7.6 years; (R1): women 44.8 ± 9.0 years, men 36.0 ± 8.0 years; (R2): women 47.1 ± 16.8, men 43.2 ±11.0. The inclusion criterion was non specific recurrent or chronic NP (longer than 3 months). The exclusion criteria were: neural tissue involvement, severe disorders of the cervical spine, other severe diseases preventing physical loading, a recent major operation, acute infection, and refusal to cooperate. 11 patients dropped out at 3 months and a further 3 patients dropped out at 12 months. Analysis was performed according to the intention‐to‐treat principle.
Interventions CBT treatment (I): 24 treatments, two sessions per week, 45 minutes each, during 12 weeks. The treatment contained (1) cervicothoracic stabilization, (2) relaxation training, (3) behavioural support, (4) eye fixation exercises, and (5) seated wobble‐board training (n = 26).
Reference treatment (R1): patients attended a lecture about NP and its consequences, received written information about neck exercises plus practical training (in smaller groups twice with 1 week interval) for home exercises (n = 25).
Reference treatment (R2): patients attended one lecture about NP and its consequences, received written information about neck exercises to be applied at home and at the workplace.(n = 25).
Outcomes 3 month after treatment self‐experienced total benefit (from 1, very much harm, to 5, very much benefit) was highest in the (I) group (mean score of 4.6) compared to (R1) group (mean score of 3.8) and (R2) group (mean score of 3.3); a similar difference was noted at 12 months. Differences between the groups in favour of the (I) group were recorded in reduction in neck symptoms and improvement in general health at 3 months, and the differences were still visible at 12 months. An improvement in self‐reported working ability in favour of the (I) group was seen at 3 months and this difference remained at the 12‐month follow‐up. VAS pain intensity score after the intervention at 3 months were significantly lower in the (I) and (R1) groups compared to the (R2) group. No statistically significant differences between the groups were noted at 12 months. No statistically discernible differences were noted among the groups in the reduction of physical impairment or FABQ score.
There were no statistically significant differences in Cervical Mobility and Pressure Pain Threshold except for Pressure Pain Threshold in the trapezius and elevator scapula muscle areas which increased in the (R1) group at 3 months, but no statistically discernible group differences were seen at 12 months.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “After the baseline measurements, the subject was randomly assigned into one of the three interventions. The randomization was performed in blocks of three stratified by sex, age, and severity of the disorder based on pain drawing.”
Comment: It is not described how the random sequence was generated.
Allocation concealment (selection bias) Unclear risk Quote: “After the baseline measurements, the subject was randomly assigned into one of the three interventions. The randomization was performed in blocks of three stratified by sex, age, and severity of the disorder based on pain drawing.”
Comment: It is not described who and how the allocation was performed.
Blinding of participants High risk Quote: “The study was a randomized, single‐blind trial of three interventions. Measurements were obtained before the randomization, after the intervention period of 3 months, and at 12 months. Researchers performing measurements and interviews were kept blinded to the interventions.”
Comment: If it is single blind and researchers were blinded, the participants were not blinded.
Blinding of personnel/ care providers (performance bias) High risk Quote: “The study was a randomized, single‐blind trial of three interventions. Measurements were obtained before the randomization, after the intervention period of 3 months, and at 12 months. Researchers performing measurements and interviews were kept blinded to the interventions.”
Comment: If it is single blind and researchers were blinded, the care providers were not blinded.
Blinding of outcome assessment (detection bias)
self‐reported measures High risk Self‐reported outcome measures were collected with the knowledge of the intervention received since participants were not blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: “The withdrawal rate was 14% (11 cases) at 3 months and 18% (14 cases) at 12 months.”
Selective reporting (reporting bias) High risk Some of the outcome measures described in the Methods were not reported in the Results section.
Group similarity at baseline (selection bias) Low risk Quote: “No statistically discernible differences were recorded in pain location, pain frequency, or use of medication between the treatment groups.”
Cointerventions (performance bias) Unclear risk Not described.
Compliance (performance bias) Unclear risk Not described.
Intention‐to‐treat‐analysis Low risk Quote: “The x2 test with cross‐tabulation tables was used in the intention‐to‐treat analyses.”
Timing of outcome assessments (detection bias) Low risk Quote: “After signing a written informed consent, all patients answered the same questionnaire and underwent the same measurement protocol three times: before and after the intervention and at 12 months (Figure 1).”