Neck Pain Clinical Trial
Official title:
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain
| NCT number | NCT02420197 |
| Other study ID # | 2014/1157 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | March 13, 2017 |
| Verified date | September 2018 |
| Source | Norwegian University of Science and Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the neck, when added to a multidisciplinary treatment program.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | March 13, 2017 |
| Est. primary completion date | March 13, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Referred to the multidisciplinary clinic for treatment of pain in the neck - Long term (= 3months) or recurrent (= 2 periods of = 4 weeks the past year) non-specific neck pain, - Pain intensity = 4 on numerical rating scale (0-10) Exclusion Criteria: - Severe somatic condition (unstable injury, malignity, infectious disease, active rheumatic disease, severe osteoporosis) - Psychiatric condition/disease that severely impairs group functioning - Insufficient comprehension of Norwegian language to participate in group sessions and fill out questionnaires - Awaiting surgery of neck - Alcohol or drug abuse - Ongoing compensation case or applying for disability benefits due to pain in the neck - Engaged in high-intensity resistance training on a regular basis the last 6 months - Contra-indications for high-intensity resistance training (i.e. shoulder complications) |
| Country | Name | City | State |
|---|---|---|---|
| Norway | St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation | Trondheim |
| Lead Sponsor | Collaborator |
|---|---|
| Norwegian University of Science and Technology | Kommunal Landspensjonskasse, Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital |
Norway,
Iversen VM, Vasseljen O, Mork PJ, Fimland MS. Resistance training vs general physical exercise in multidisciplinary rehabilitation of chronic neck pain: A randomized controlled trial. J Rehabil Med. 2018 Aug 22;50(8):743-750. doi: 10.2340/16501977-2370. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neck-related disability as assessed by the neck disability index | Neck disability index | 12 weeks | |
| Secondary | Pain assessed by the Numerical Pain Rating Scale | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Patient's` perceived effect of the treatment assessed by the Patient specific functioning scale | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Anxiety and depression assessed by Hopkins symptom checklist | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Quality of life assessed by EQ-5D-5L | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Work ability assessed by Work ability index | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Use of analgesics assessed by a questionnaire from the HUNT study | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Physical activity level assessed by a questionnaire from the HUNT study | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Strength in the neck measured using a handheld dynamometer | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Pressure pain threshold of the tibialis anterior muscle measured using an algometer | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Grip strength measured using a handheld dynamometer | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Patient's` perceived effect of the treatment assessed by the Global rating of change scale | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Neck-related disability as assessed by the neck disability index | 3 weeks + 6 and 12 months |
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