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Stretching and Pain Sensitivity

Primary Purpose

Stretching

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Calf muscle stretching

About this trial

This is an interventional basic science trial for Stretching

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged between 18 and 40
In general good health, in the opinion of the Investigator, based on medical and physical history.
Speaks, reads and writes Danish language.

Exclusion Criteria:

Regular use of stretching
History of surgery to the lower limb(s)
History of traumatic and overuse injures to the lower limb(s), including but not limited to: Tendinopathies, Bursitis, Muscle injuries, Significant ankle sprains, other ligament injuries
Hyper mobility syndromes, including but not limited to Ehlers-Danlos syndrome, Generalised hyper mobility syndrome
History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis).
Planned surgical procedure during the duration of the study
History, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to: Stroke or transient ischemic attack, Alzheimer's disease or other types of dementia, Clinically significant head trauma within the past year, Peripheral neuropathy, Epilepsy or seizure, Impaired balance
Alcohol or drug abuse within the last 5 years
History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
Diabetes
Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.
Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.

Sites / Locations

The Parker Institute, Bispebjerg and Frederiksberg University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stretching

Control

Arm Description

Daily stretching of the calf (dominant side; defined as leg used to kick a ball). 2 stretching exercises are performed daily: 1) stretching of the soleus muscle; 2) stretching of the gastrocnemius muscle.

Outcomes

Primary Outcome Measures

Change from baseline in pressure pain threshold (PPT) at the ipsilateral (same side as being stretched) calf assessed by a cuff pressure algometer

Secondary Outcome Measures

Change from baseline in PPT at the counter lateral calf

Change from baseline in PPT at the ipsilateral arm

Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm.

Full Information

NCT ID

NCT02027766

First Posted

January 3, 2014

Last Updated

May 5, 2014

Sponsor

Marius Henriksen

1. Study Identification

Unique Protocol Identification Number

NCT02027766

Brief Title

Stretching and Pain Sensitivity

Official Title

Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle-tendon Stretching: A Randomised Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marius Henriksen

4. Oversight

5. Study Description

Brief Summary

Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and to prevent sports injuries. It is not known if stretching affects pain sensitivity. The purpose of this study is to investigate if a 4 week daily stretching protocol alters pain sensitivity. The investigators hypothesize that stretching reduces pain sensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stretching

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stretching

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Calf muscle stretching

Primary Outcome Measure Information:

Title

Change from baseline in pressure pain threshold (PPT) at the ipsilateral (same side as being stretched) calf assessed by a cuff pressure algometer

Time Frame

Baseline and after 4 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in PPT at the counter lateral calf

Time Frame

Baseline and 4 weeks

Title

Change from baseline in PPT at the ipsilateral arm

Time Frame

baseline and 4 weeks

Title

Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm.

Time Frame

Baseline and after 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged between 18 and 40 In general good health, in the opinion of the Investigator, based on medical and physical history. Speaks, reads and writes Danish language. Exclusion Criteria: Regular use of stretching History of surgery to the lower limb(s) History of traumatic and overuse injures to the lower limb(s), including but not limited to: Tendinopathies, Bursitis, Muscle injuries, Significant ankle sprains, other ligament injuries Hyper mobility syndromes, including but not limited to Ehlers-Danlos syndrome, Generalised hyper mobility syndrome History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis). Planned surgical procedure during the duration of the study History, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to: Stroke or transient ischemic attack, Alzheimer's disease or other types of dementia, Clinically significant head trauma within the past year, Peripheral neuropathy, Epilepsy or seizure, Impaired balance Alcohol or drug abuse within the last 5 years History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder Diabetes Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy. Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marius Henriksen, PT, PhD

Organizational Affiliation

Frederiksberg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Parker Institute, Bispebjerg and Frederiksberg University Hospitals

City

Copenhagen

ZIP/Postal Code

2000

Country

Denmark

12. IPD Sharing Statement

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Stretching and Pain Sensitivity

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