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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02420197
Date of registration: 18/03/2015
Prospective Registration: No
Primary sponsor: Norwegian University of Science and Technology
Public title: Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain
Scientific title: Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain
Date of first enrolment: January 2015
Target sample size: 74
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02420197
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).  
Phase:  N/A
Countries of recruitment
Norway
Contacts
Name:     Marius S Fimland, phd
Address: 
Telephone:
Email:
Affiliation:  Norwegian University of Science and Technology
Key inclusion & exclusion criteria

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)



Age minimum: 16 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Neck Pain
Intervention(s)
Behavioral: General physical activity
Behavioral: Multidisciplinary rehabilitation program
Behavioral: High-intensity resistance training
Primary Outcome(s)
Neck-related disability as assessed by the neck disability index [Time Frame: 12 weeks]
Secondary Outcome(s)
Neck-related disability as assessed by the neck disability index [Time Frame: 3 weeks + 6 and 12 months]
Pain assessed by the Numerical Pain Rating Scale [Time Frame: 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]
Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire [Time Frame: 3 and 12 weeks + 6 and 12 months]
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]
Physical activity level assessed by a questionnaire from the HUNT study [Time Frame: 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]
Anxiety and depression assessed by Hopkins symptom checklist [Time Frame: 3 and 12 weeks + 6 and 12 months]
Grip strength measured using a handheld dynamometer [Time Frame: 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]
Use of analgesics assessed by a questionnaire from the HUNT study [Time Frame: 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]
Work ability assessed by Work ability index [Time Frame: 3 and 12 weeks + 6 and 12 months]
Secondary ID(s)
2014/1157
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Kommunal Landspensjonskasse
Norwegian Fund for Postgraduate Training in Physiotherapy
St. Olavs Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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