Low Back PainNCT02420236
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain
A study testing High-intensity resistance training, General physical activity and Multidisciplinary rehabilitation program in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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 low back, when added to a multidisciplinary treatment program. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- High-intensity resistance training, General physical activity and Multidisciplinary rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to 15 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referred to the multidisciplinary clinic for treatment of pain in low back
- Long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific low back pain
- Pain intensity ≥ 4 on numerical rating scale (0-10)
Who cannot join
- 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 back
- Alcohol or drug abuse
- Ongoing compensation case or applying for disability benefits due to pain in the back
- Engaged in high-intensity resistance training on a regular basis the last 6 months
Trial locations and contacts
1 site in 1 country.
Norway1 site
St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation
Trondheim
About this study
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 low back, when added to a multidisciplinary treatment program.
- Conditions
- Low Back Pain
- Being tested
- High-intensity resistance training, General physical activity, Multidisciplinary rehabilitation program
- Keywords
- Exercise therapy, Resistance training, Multidisciplinary treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity resistance trainingBehavioural
General physical activityBehavioural
Multidisciplinary rehabilitation programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High-intensity resistance training; Behavioral: 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. Receives: Behavioral: General physical activity; Behavioral: Multidisciplinary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back-related disability as assessed by the oswestry disability index
Oswestry disability index
Measured: 12 weeks
Secondary outcomes (12)
Pain assessed by the Numerical Pain Rating Scale
Measured: 3 and 12 weeks + 6 and 12 months
Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire
Measured: 3 and 12 weeks + 6 and 12 months
Patients' perceived effect of the treatment assessed by the Patient specific functioning scale
Measured: 3 and 12 weeks + 6 and 12 months
Anxiety and depression assessed by Hopkins symptom checklist
Measured: 3 and 12 weeks + 6 and 12 months
Quality of life assessed by EQ-5D-5L
Measured: 3 and 12 weeks + 6 and 12 months
Work ability assessed by Work ability index
Measured: 3 and 12 weeks + 6 and 12 months
Use of analgesics assessed by a questionnaire from the HUNT study
Measured: 3 and 12 weeks + 6 and 12 months
Physical activity level assessed by a questionnaire from the HUNT study
Measured: 3 and 12 weeks + 6 and 12 months
Strength in the low back during maximal isometric contractions of the back extensors
Measured: 3 and 12 weeks + 6 and 12 months
Grip strength using a handheld dynamometer
Measured: 3 and 12 weeks + 6 and 12 months
Patients' perceived effect of the treatment assessed by the Global rating of change scale
Measured: 3 and 12 weeks + 6 and 12 months
Low back-related disability as assessed by the oswestry disability index
Measured: 3 weeks + 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJan 2015
- Primary completion4 Jan 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy, Kommunal Landspensjonskasse
- Responsible party
- Sponsor
- Investigators
- Marius S Fimland, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420236
- Sponsor's protocol ID
- 2014/1157-B
- Status last verified
- Jun 2018
- First submitted
- 18 Mar 2015
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iversen VM, Vasseljen O, Mork PJ, Berthelsen IR, Borke JB, Berheussen GF, Tveter AT, Salvesen O, Fimland MS. Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol. Contemp Clin Trials Commun. 2017 Apr 12;6:115-121. doi: 10.1016/j.conctc.2017.04.001. eCollection 2017 Jun.
PubMed 29740641Iversen VM, Vasseljen O, Mork PJ, Gismervik S, Bertheussen GF, Salvesen O, Fimland MS. Resistance band training or general exercise in multidisciplinary rehabilitation of low back pain? A randomized trial. Scand J Med Sci Sports. 2018 Sep;28(9):2074-2083. doi: 10.1111/sms.13091. Epub 2018 Apr 24.
PubMed 29603805
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain
- ClinicalTrials.gov ID
- NCT02420236
- Acronym / sponsor ID
- 2014/1157-B
- Conditions
- Low Back Pain
- Keywords
- Exercise therapy, Resistance training, Multidisciplinary treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy, Kommunal Landspensjonskasse
- Study start
- Jan 2015 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 low back, when added to a multidisciplinary treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity resistance training | Experimental | Behavioral: High-intensity resistance training, Behavioral: Multidisciplinary rehabilitation programFull 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. |
| General physical activity | Active comparator | Behavioral: General physical activity, Behavioral: Multidisciplinary rehabilitation program12 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Referred to the multidisciplinary clinic for treatment of pain in low back
- Long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific low back pain
- Pain intensity ≥ 4 on numerical rating scale (0-10)
Key exclusion criteria (7 listed)
- 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 back
- Alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity resistance training | Behavioural | High-intensity resistance training |
| General physical activity | Behavioural | General physical activity |
| Multidisciplinary rehabilitation program | Behavioural | General physical activity, High-intensity resistance training |
Primary outcome
Low back-related disability as assessed by the oswestry disability index
Time frame: 12 weeks
Oswestry disability index
12 secondary outcomes
Pain assessed by the Numerical Pain Rating Scale
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
Patients' perceived effect of the treatment assessed by the Patient specific functioning scale
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
Quality of life assessed by EQ-5D-5L
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
Use of analgesics assessed by a questionnaire from the HUNT study
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
Strength in the low back during maximal isometric contractions of the back extensors
Time frame: 3 and 12 weeks + 6 and 12 months
Grip strength using a handheld dynamometer
Time frame: 3 and 12 weeks + 6 and 12 months
Patients' perceived effect of the treatment assessed by the Global rating of change scale
Time frame: 3 and 12 weeks + 6 and 12 months
Low back-related disability as assessed by the oswestry disability index
Time frame: 3 weeks + 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Background: PubMed 29740641Iversen VM, Vasseljen O, Mork PJ, Berthelsen IR, Borke JB, Berheussen GF, Tveter AT, Salvesen O, Fimland MS. Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol. Contemp Clin Trials Commun. 2017 Apr 12;6:115-121. doi: 10.1016/j.conctc.2017.04.001. eCollection 2017 Jun.
- Results publication: PubMed 29603805Iversen VM, Vasseljen O, Mork PJ, Gismervik S, Bertheussen GF, Salvesen O, Fimland MS. Resistance band training or general exercise in multidisciplinary rehabilitation of low back pain? A randomized trial. Scand J Med Sci Sports. 2018 Sep;28(9):2074-2083. doi: 10.1111/sms.13091. Epub 2018 Apr 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius S Fimland, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity resistance training, General physical activity and Multidisciplinary rehabilitation program in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back-related disability as assessed by the oswestry disability index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420236, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.