NCT02027766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

January 3, 2014

Last Update Submit

May 5, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Baseline and after 4 weeks

Secondary Outcomes (3)

  • Change from baseline in PPT at the counter lateral calf

    Baseline and 4 weeks

  • Change from baseline in PPT at the ipsilateral arm

    baseline and 4 weeks

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

    Baseline and after 4 weeks

Study Arms (2)

Stretching

EXPERIMENTAL

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.

Other: Calf muscle stretching

Control

NO INTERVENTION

Interventions

Stretching

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute, Bispebjerg and Frederiksberg University Hospitals

Copenhagen, 2000, Denmark

Location

Study Officials

  • Marius Henriksen, PT, PhD

    Frederiksberg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 6, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations