search
Back to results

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

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Stretching and aerobic exercise
Strength training
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring chronic, neck, shoulder, exercise

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Health Sciences, Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: Stretching and aerobic exercise

Group 2: Strength training

Arm Description

Group 1 undertook a stretching programme for neck/shoulder muscles three times weekly and performed aerobic exercise för 30 minutes three times weekly.

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.

Outcomes

Primary Outcome Measures

Pain
Methods of measurement: Surveys, physical tests, microdialysis.
Function
Methods of measurement: Surveys, physical tests, microdialysis.

Secondary Outcome Measures

Muscle biochemistry
Biochemical substances from the interstitium of the trapezius muscle will be determined eg, serotonin, glutmate, lactate, pyruvate, endocannabinoids.
Psychological factors
Aspects concerning psychological distress will be followed eg depression and anxiety using Hospital Anxiety and Depression Scale (HADS).
Pain sensitivity
Pain thresholds for pressure (algometry) and heat and cold (QST) will be registered.

Full Information

First Posted
September 5, 2011
Last Updated
June 10, 2013
Sponsor
Linkoeping University
search

1. Study Identification

Unique Protocol Identification Number
NCT01876680
Brief Title
The Effects of Two Different Home-exercise Programmes on Women Suffering Long Term Neck/Shoulder Muscle Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
chronic, neck, shoulder, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Stretching and aerobic exercise
Arm Type
Experimental
Arm Description
Group 1 undertook a stretching programme for neck/shoulder muscles three times weekly and performed aerobic exercise för 30 minutes three times weekly.
Arm Title
Group 2: Strength training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching and aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Methods of measurement: Surveys, physical tests, microdialysis.
Time Frame
Before training, 4-6 months and after one year of training.
Title
Function
Description
Methods of measurement: Surveys, physical tests, microdialysis.
Time Frame
Before training, 4-6 months and after one year of training.
Secondary Outcome Measure Information:
Title
Muscle biochemistry
Description
Biochemical substances from the interstitium of the trapezius muscle will be determined eg, serotonin, glutmate, lactate, pyruvate, endocannabinoids.
Time Frame
Before training, 4-6 months follow-up and 12 months follow-up
Title
Psychological factors
Description
Aspects concerning psychological distress will be followed eg depression and anxiety using Hospital Anxiety and Depression Scale (HADS).
Time Frame
Before training, 4-6 months follow-up and 12 months follow-up
Title
Pain sensitivity
Description
Pain thresholds for pressure (algometry) and heat and cold (QST) will be registered.
Time Frame
Before training, 4-6 months follow-up and 12 months follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt Larsson, Assoc Prof
Organizational Affiliation
rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences, Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
SE 581 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24995488
Citation
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.
Results Reference
derived
PubMed Identifier
24400934
Citation
Karlsson 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.
Results Reference
derived
Links:
URL
http://www.liu.se
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs