Clinical trial NCT02420197: Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain
Official title: Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Exercise therapy
Resistance training
Multidisciplinary treatment
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: Kommunal Landspensjonskasse
First posted: 2015-04-17
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Neck-related disability as assessed by the neck disability index
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain assessed by the Numerical Pain Rating Scale
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Patient's' perceived effect of the treatment assessed by the Patient specific functioning scale
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Anxiety and depression assessed by Hopkins symptom checklist
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Quality of life assessed by EQ-5D-5L
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Work ability assessed by Work ability index
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Use of analgesics assessed by a questionnaire from the HUNT study
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Physical activity level assessed by a questionnaire from the HUNT study
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Strength in the neck measured using a handheld dynamometer
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Pressure pain threshold of the tibialis anterior muscle measured using an algometer
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Grip strength measured using a handheld dynamometer
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Patient's' perceived effect of the treatment assessed by the Global rating of change scale
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Neck-related disability as assessed by the neck disability index
timeFrame: 3 weeks + 6 and 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Norwegian University of Science and Technology
name: Marius S Fimland, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.