- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420197
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain
September 20, 2018 updated by: Norwegian University of Science and Technology
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Trondheim, Norway
- St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-intensity resistance training
Full body, progressive strength training with Theraband® Elastic bands.
Three times per week for 12 weeks - 3 weeks with supervised sessions at the clinic, and 9 weeks of home training.Three guided sessions will be offered during the home training period.
|
|
Active Comparator: General physical activity
12 weeks of general physical activity - 3 weeks with supervised sessions at the clinic, and 9 weeks of individually adjusted home training.
This include circle-training, low-intensity resistance exercises, endurance exercises, ball playing, body awareness, stretching, and relaxation techniques, and similar activities.
Neither moderate nor high-intensity resistance exercise is included for participants in this group.Three guided sessions will be offered during the home training period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck-related disability as assessed by the neck disability index
Time Frame: 12 weeks
|
Neck disability index
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain assessed by the Numerical Pain Rating Scale
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Patient's' perceived effect of the treatment assessed by the Patient specific functioning scale
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Anxiety and depression assessed by Hopkins symptom checklist
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Quality of life assessed by EQ-5D-5L
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Work ability assessed by Work ability index
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Use of analgesics assessed by a questionnaire from the HUNT study
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Physical activity level assessed by a questionnaire from the HUNT study
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Strength in the neck measured using a handheld dynamometer
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
|
Pressure pain threshold of the tibialis anterior muscle measured using an algometer
Time Frame: 3 and 12 weeks + 6 and 12 months
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3 and 12 weeks + 6 and 12 months
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Grip strength measured using a handheld dynamometer
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
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Patient's' perceived effect of the treatment assessed by the Global rating of change scale
Time Frame: 3 and 12 weeks + 6 and 12 months
|
3 and 12 weeks + 6 and 12 months
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Neck-related disability as assessed by the neck disability index
Time Frame: 3 weeks + 6 and 12 months
|
3 weeks + 6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marius S Fimland, PhD, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
March 13, 2017
Study Completion (Actual)
March 13, 2017
Study Registration Dates
First Submitted
March 18, 2015
First Submitted That Met QC Criteria
April 14, 2015
First Posted (Estimate)
April 17, 2015
Study Record Updates
Last Update Posted (Actual)
September 24, 2018
Last Update Submitted That Met QC Criteria
September 20, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1157
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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