The Effects of Two Different Home-exercise Programmes on Women Suffering Long Term Neck/Shoulder Muscle Pain

June 10, 2013 updated by: Bjorn Gerdle, Linkoeping University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, SE 581 85
        • Faculty of Health Sciences, Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • 20-60
  • long term neck/shoulder muscle pain
  • willing to exercise

Exclusion Criteria:

  • widespread pain
  • pregnancy
  • major trauma in medical history
  • tendonitis in upper extremities
  • neurological causes of the pain
  • inflammatory and hormonal disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Stretching and aerobic exercise
Group 1 undertook a stretching programme for neck/shoulder muscles three times weekly and performed aerobic exercise för 30 minutes three times weekly.
Other: Stretching and aerobic exercise

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.
Experimental: Group 2: Strength training
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.
Other: Strength training

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Before training, 4-6 months and after one year of training.
Methods of measurement: Surveys, physical tests, microdialysis.
Before training, 4-6 months and after one year of training.
Function
Time Frame: Before training, 4-6 months and after one year of training.
Methods of measurement: Surveys, physical tests, microdialysis.
Before training, 4-6 months and after one year of training.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle biochemistry
Time Frame: Before training, 4-6 months follow-up and 12 months follow-up
Biochemical substances from the interstitium of the trapezius muscle will be determined eg, serotonin, glutmate, lactate, pyruvate, endocannabinoids.
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
Aspects concerning psychological distress will be followed eg depression and anxiety using Hospital Anxiety and Depression Scale (HADS).
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
Pain thresholds for pressure (algometry) and heat and cold (QST) will be registered.
Before training, 4-6 months follow-up and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Britt Larsson, Assoc Prof, rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 5, 2011

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIU-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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