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Completed

NCT Number: NCT04919681

Efficacy of Stretching on Pain Sensitivity

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College of Northern Denmark

Aalborg, 9220, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stretch exercises

Other

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.

Primary outcomes

  1. Pain sensitivity

    Time frame: Baseline

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

  2. Pain sensitivity

    Time frame: 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

    Time frame: 10 weeks

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

Secondary outcomes

  1. Range of motion

    Time frame: Baseline

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

  2. Range of motion

    Time frame: 6 weeks

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

  3. Range of motion

    Time frame: 10 weeks

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

  4. Passive resistive torque

    Time frame: Baseline

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

  5. Passive resistive torque

    Time frame: 6 weeks

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

  6. Passive resistive torque

    Time frame: 10 weeks

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

Other outcomes

  1. Adherence to the stretching protocol

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

University College of Northern Denmark

Other

Collaborators

  • Bispebjerg Hospital
  • Research Unit for General Practice in Aalborg
  • University of Copenhagen

Registry information

Official study title

Efficacy of a Stretching Protocol on Regional and Distant Pain Sensitivity:

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2021
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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