Efficacy of Stretching on Pain Sensitivity

• Sponsor: University College of Northern Denmark (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04919681
• Collaborator: Bispebjerg Hospital (Other), University of Copenhagen (Other), Research Unit of General Practice, Aalborg (Other)
• Enrollment: 26
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

The primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching.

The secondary objective of the study is to determine the effect after four-week cessation of the stretching protocol on regional and distant pain sensitivity. If regional and distant pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic effect will abate following four-week cessation.

Condition or Disease	Intervention/Treatment	Phase
Pain Threshold	Other: Stretch exercises	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single-blind longitudinal repeated measures studySingle-blind longitudinal repeated measures study
• Masking: None (Open Label)
• Masking Description: Participants are blinded to the results of the pressure pain threshold measurements. Participants and examiner are blinded to the results of the range of motion and passive resistive torque measurements.
• Primary Purpose: Basic Science
• Official Title: Efficacy of a Stretching Protocol on Regional and Distant Pain Sensitivity:
• Actual Study Start Date: Nov 4, 2021
• Actual Primary Completion Date: Apr 25, 2022
• Anticipated Study Completion Date: Aug 20, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Stretching Static stretching of the knee flexors

Other: Stretch exercises; The intervention comprises of six weeks daily bi-lateral static stretching of the knee flexors. Stretches are performed seated on the ground. The participant sits upright on the floor with one leg straight. The sole of the other foot should be placed on the inside of the outstretched leg. The participant leans slightly forward, trying to touch their toes while maintaining full knee extension. Stretching is performed to the point of discomfort, and each stretch is held for 30-seconds for three repetitions.

Outcome Measures

Primary Outcome Measures

1. Pain sensitivity [Baseline]

   The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer

2. Pain sensitivity [6 weeks]

   The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer

3. Pain sensitivity [10 weeks]

   The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer

Secondary Outcome Measures

1. Range of motion [Baseline]

   Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer

2. Range of motion [6 weeks]

   Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer

3. Range of motion [10 weeks]

   Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer

4. Passive resistive torque [Baseline]

   Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer

5. Passive resistive torque [6 weeks]

   Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer

6. Passive resistive torque [10 weeks]

   Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer

Other Outcome Measures

1. Adherence to the stretching protocol [6 weeks]

   Adherence to the stretching protocol will be measured using self-reported data from an mHealth app.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy men and women aged 18-65 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Participants are included if they have no known medical conditions such as

• cognitive impairments,

• neurological,

• orthopaedic,

• or neuromuscular problems that might affect the somatosensory system or preclude stretching exercises or range of motion testing at the knee.

Exclusion Criteria:

• Individuals who regularly engage in flexibility training (e.g., stretching, tai chi, pilates or yoga)

• or use any medication that might affect the somatosensory system, such as pain medication, are excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University College of Northern Denmark	Aalborg		Denmark	9220

Sponsors and Collaborators

• University College of Northern Denmark
• Bispebjerg Hospital
• University of Copenhagen
• Research Unit of General Practice, Aalborg

Investigators

• Study Director: Dorte Drachmann, Msc., Department of physiotherapy, University College of Northern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Morten Pallisgaard, Associate Lecturer, University College of Northern Denmark
• ClinicalTrials.gov Identifier: NCT04919681
• Other Study ID Numbers: UniversityCND3
• First Posted: Jun 9, 2021
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Morten Pallisgaard, Associate Lecturer, University College of Northern Denmark: Stretching; Pain sensitivity; Range of motion; Exercise adherence
• Additional relevant MeSH terms: Hypersensitivity

Study Results

No Results Posted as of May 19, 2022