Neck PainPhase 2NCT01876680
The Effects of Two Different Home-exercise Programmes on Women Suffering Long Term Neck/Shoulder Muscle Pain
A Phase 2 study testing Stretching and aerobic exercise and Strength training in people with Neck Pain, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the effects of specific neck/shoulder muscle exercises on pain, function, biochemistry and psychological factors in women suffering chronic neck/shoulder pain. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Neck Pain
- What is being tested?
- Stretching and aerobic exercise and Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Jul 2011
- Phase
- Phase 2
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female
- 20-60
- long term neck/shoulder muscle pain
- willing to exercise
Who cannot join
- widespread pain
- pregnancy
- major trauma in medical history
- tendonitis in upper extremities
- neurological causes of the pain
- inflammatory and hormonal disorders
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Faculty of Health Sciences, Linköping University
Linköping, Östergötland County, SE 581 85
About this study
Official title: The Effects (Pain, Function, Biochemistry and Psychological Factors) of Two Different Home-exercise Programmes on Women Suffering Long Term Nack/Shoulder Muscle Pain
The purpose of this study is to investigate the effects of specific neck/shoulder muscle exercises on pain, function, biochemistry and psychological factors in women suffering chronic neck/shoulder pain.
- Conditions
- Neck Pain
- Being tested
- Stretching and aerobic exercise, Strength training
- Keywords
- chronic, neck, shoulder, exercise
- Medical subject headings
- Neck Pain, Bronchiolitis Obliterans Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching and aerobic exerciseOther
Stretching programme for neck/shoulder muscles three times weekly and aerobic exercise för 30 minutes three times weekly.
Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year.
Strength trainingOther
Stretching programme for neck/shoulder muscles three times weekly, aerobic exercise för 30 minutes three times weekly and weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly.
Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Stretching and aerobic exercise | Experimental | Group 1 undertook a stretching programme for neck/shoulder muscles three times weekly and performed aerobic exercise för 30 minutes three times weekly. Receives: Other: Stretching and aerobic exercise |
| Group 2: Strength training | Experimental | Group 2 undertook a stretching programme for neck/shoulder muscles three times weekly, performed aerobic exercise three times weekly and performed weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly. Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Methods of measurement: Surveys, physical tests, microdialysis.
Measured: Before training, 4-6 months and after one year of training.
Function
Methods of measurement: Surveys, physical tests, microdialysis.
Measured: Before training, 4-6 months and after one year of training.
Secondary outcomes (3)
Muscle biochemistry
Biochemical substances from the interstitium of the trapezius muscle will be determined eg, serotonin, glutmate, lactate, pyruvate, endocannabinoids.
Measured: Before training, 4-6 months follow-up and 12 months follow-up
Psychological factors
Aspects concerning psychological distress will be followed eg depression and anxiety using Hospital Anxiety and Depression Scale (HADS).
Measured: Before training, 4-6 months follow-up and 12 months follow-up
Pain sensitivity
Pain thresholds for pressure (algometry) and heat and cold (QST) will be registered.
Measured: Before training, 4-6 months follow-up and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startSep 2009
- Primary completionJul 2011
- Study completionJul 2011
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 Neck PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bjorn Gerdle, Linkoeping University
- Investigators
- Britt Larsson, Assoc Prof, Principal investigator, rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876680
- Sponsor's protocol ID
- LIU-001
- Status last verified
- Jun 2013
- First submitted
- 5 Sep 2011
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghafouri N, Ghafouri B, Fowler CJ, Larsson B, Turkina MV, Karlsson L, Gerdle B. Effects of two different specific neck exercise interventions on palmitoylethanolamide and stearoylethanolamide concentrations in the interstitium of the trapezius muscle in women with chronic neck shoulder pain. Pain Med. 2014 Aug;15(8):1379-89. doi: 10.1111/pme.12486. Epub 2014 Jul 4.
PubMed 24995488Karlsson L, Takala EP, Gerdle B, Larsson B. Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders. BMC Musculoskelet Disord. 2014 Jan 8;15:6. doi: 10.1186/1471-2474-15-6.
PubMed 24400934
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects (Pain, Function, Biochemistry and Psychological Factors) of Two Different Home-exercise Programmes on Women Suffering Long Term Nack/Shoulder Muscle Pain
- ClinicalTrials.gov ID
- NCT01876680
- Acronym / sponsor ID
- LIU-001
- Conditions
- Neck Pain
- Keywords
- chronic, neck, shoulder, exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Sep 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Jun 2013 (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 the effects of specific neck/shoulder muscle exercises on pain, function, biochemistry and psychological factors in women suffering chronic neck/shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Stretching and aerobic exercise | Experimental | Other: Stretching and aerobic exerciseGroup 1 undertook a stretching programme for neck/shoulder muscles three times weekly and performed aerobic exercise för 30 minutes three times weekly. |
| Group 2: Strength training | Experimental | Other: Strength trainingGroup 2 undertook a stretching programme for neck/shoulder muscles three times weekly, performed aerobic exercise three times weekly and performed weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female
- 20-60
- long term neck/shoulder muscle pain
- willing to exercise
Key exclusion criteria (6 listed)
- widespread pain
- pregnancy
- major trauma in medical history
- tendonitis in upper extremities
- neurological causes of the pain
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 |
|---|---|---|
| Stretching and aerobic exerciseStretching programme for neck/shoulder muscles three times weekly and aerobic exercise för 30 minutes three times weekly. Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year. | Other | Group 1: Stretching and aerobic exercise |
| Strength trainingStretching programme for neck/shoulder muscles three times weekly, aerobic exercise för 30 minutes three times weekly and weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly. Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year. | Other | Group 2: Strength training |
Primary outcome
Pain
Time frame: Before training, 4-6 months and after one year of training.
Methods of measurement: Surveys, physical tests, microdialysis.
Function
Time frame: Before training, 4-6 months and after one year of training.
Methods of measurement: Surveys, physical tests, microdialysis.
3 secondary outcomes
Muscle biochemistry
Time frame: Before training, 4-6 months follow-up and 12 months follow-up
Psychological factors
Time frame: Before training, 4-6 months follow-up and 12 months follow-up
Pain sensitivity
Time frame: Before training, 4-6 months follow-up and 12 months follow-up
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 12 Jun 2013.
- Derived from this study: PubMed 24995488Ghafouri N, Ghafouri B, Fowler CJ, Larsson B, Turkina MV, Karlsson L, Gerdle B. Effects of two different specific neck exercise interventions on palmitoylethanolamide and stearoylethanolamide concentrations in the interstitium of the trapezius muscle in women with chronic neck shoulder pain. Pain Med. 2014 Aug;15(8):1379-89. doi: 10.1111/pme.12486. Epub 2014 Jul 4.
- Derived from this study: PubMed 24400934Karlsson L, Takala EP, Gerdle B, Larsson B. Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders. BMC Musculoskelet Disord. 2014 Jan 8;15:6. doi: 10.1186/1471-2474-15-6.
- Related InfoLink provided by the sponsor.
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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.
Britt Larsson, Assoc Prof principal investigator
rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stretching and aerobic exercise and Strength training in people with Neck Pain, run by Linkoeping University at 1 site in Sweden.
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 4 inclusion and 6 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 12 Jun 2013. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (time frame: Before training, 4-6 months and after one year of training.). The study lists 2 primary outcomes in all. 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 NCT01876680, 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 12 Jun 2013.