NCT02420197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2017

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

March 18, 2015

Last Update Submit

September 20, 2018

Conditions

Neck Pain

Keywords

Exercise therapyResistance trainingMultidisciplinary treatment

Outcome Measures

Primary Outcomes (1)

  • Neck-related disability as assessed by the neck disability index

    Neck disability index

    12 weeks

Secondary Outcomes (13)

  • Pain assessed by the Numerical Pain Rating Scale

    3 and 12 weeks + 6 and 12 months

  • Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire

    3 and 12 weeks + 6 and 12 months

  • Patient's' perceived effect of the treatment assessed by the Patient specific functioning scale

    3 and 12 weeks + 6 and 12 months

  • Anxiety and depression assessed by Hopkins symptom checklist

    3 and 12 weeks + 6 and 12 months

  • Quality of life assessed by EQ-5D-5L

    3 and 12 weeks + 6 and 12 months

  • +8 more secondary outcomes

Study Arms (2)

High-intensity resistance training

EXPERIMENTAL

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.

Behavioral: High-intensity resistance trainingBehavioral: Multidisciplinary rehabilitation program

General physical activity

ACTIVE COMPARATOR

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.

Behavioral: General physical activityBehavioral: Multidisciplinary rehabilitation program

Interventions

High-intensity resistance trainingBEHAVIORAL
High-intensity resistance training
General physical activityBEHAVIORAL
General physical activity
Multidisciplinary rehabilitation programBEHAVIORAL
General physical activityHigh-intensity resistance training

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 30132009RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marius S Fimland, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 17, 2015

Study Start

January 1, 2015

Primary Completion

March 13, 2017

Study Completion

March 13, 2017

Last Updated

September 24, 2018

Record last verified: 2018-09

Locations

NO(1)