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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01876680
Other study ID # LIU-001
Secondary ID
Status Completed
Phase Phase 2
First received September 5, 2011
Last updated June 10, 2013
Start date September 2009
Est. completion date July 2011

Study information

Verified date June 2013
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Sweden Faculty of Health Sciences, Linköping University Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Methods of measurement: Surveys, physical tests, microdialysis. Before training, 4-6 months and after one year of training. No
Primary Function Methods of measurement: Surveys, physical tests, microdialysis. Before training, 4-6 months and after one year of training. No
Secondary Muscle biochemistry 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 No
Secondary Psychological factors 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 No
Secondary Pain sensitivity 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 No
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