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Clinical Trials/NCT03882333
NCT03882333CompletedNot Applicable

Effects of Acute Exercise on Pain and Human Movement - a Randomised Controlled Study in Patients With Chronic Pain and Healthy Controls

Dalarna University2 sites in 1 country82 target enrollmentStarted: December 12, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
82
Locations
2
Primary Endpoint
Kinematic measures of human movement during functional gait sequences

Study Overview

Brief Summary

The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement con-trol between patients with chronic musculoskeletal pain compared to healthy controls.

Detailed Description

The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement control between patients with chronic musculoskeletal pain compared to healthy controls. All tests will be conducted at Dalarna University.

After the initial baseline tests, participants will be randomised to either acute exercise intervention group or to a control group not performing any intervention groups (both patients and controls will be randomised to intervention or control). If randomised to the control group, participants rests corresponding to the time it takes to perform the intervention (30 min), and then preform the post-intervention tests similar as the intervention group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 67 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Inclusion criteria for participants with chronic pain:
  • Men and women, age 18-67 years,
  • good ability to understand written and verbal information and instruction given in Swedish,
  • chronic (>3 months) musculoskeletal pain or chronic widespread pain.
  • Inclusion criteria for healthy controls:
  • Men and women, age 18-67 years,
  • good ability to understand written and verbal information and instruction given in Swedish.

Exclusion Criteria

  • For participants with chronic pain
  • chronic pain caused by malignancies or systemic diseases, other physical conditions that affects functional abilities and implies use of walking aid in-door,
  • pregnancy after week 12, childbirth within the last 3 months or
  • spinal surgery.
  • For healthy controls:
  • chronic (>3 months) or acute pain of any cause,
  • other physical conditions that affects functional abilities, and implies use of walking aids in-door,
  • pregnancy after week 12, childbirth in the last 3 months or
  • spinal surgery.

Outcomes

Primary Outcomes

Kinematic measures of human movement during functional gait sequences

Time Frame: 30 minutes (before and after the acute exercise intervention)

Objective measures of movement control using sophisticated wearable sensors (accelerometer-based APDM-sensors applied at participants wrists, ankles, chest and head) during walking in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test: participants listens to a recording of a voice that presents random series of digits between 1 to 9 with two seconds apart. The participants will be instructed to respond as quickly and accurately as possible, repeating the digit before the last one in the sequence.). Lumbar trunk rotations (degrees) will specifically be evaluated while many other kinematic variables (walking speed, step length, step width etc) will be analyzed with factor analyz-es to reduce data variables to relevant data domains, such as gait stability. Data will be aggregated as means and variances.

Muscle activity

Time Frame: 30 minutes (before and after the acute exercise intervention)

Evaluation of back muscle activity using electromyographics (EMG) during walking as in outcome 1, i.e. in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test). Participants will be instrumented with surface-EMG (Delsys Incorporated, Massachusetts) electrodes applied bilateral at participants back and neck muscles. Back and neck spatial and temporal muscle activity (EMG amplitudes) representing repeated gait cycles will be aggregated to one cycle; factor analyzes may be applied to reduce data variables to relevant data domains. Data will be presented as means and variances.

Secondary Outcomes

  • Self-rated pain using the Visual Analogue Scale (VAS scale).(30 minutes (before and after the acute exercise intervention))

Investigators

Sponsor
Dalarna University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bjorn Ang

Associate Professor

Karolinska Institutet

Study Sites (2)

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