NCT03882333

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

December 12, 2018

Last Update Submit

September 8, 2021

Conditions

Keywords

Chronic musculoskeletal painAcute exerciseMovement controlMuscle activity

Outcome Measures

Primary Outcomes (2)

  • Kinematic measures of human movement during functional gait sequences

    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.

    30 minutes (before and after the acute exercise intervention)

  • Muscle activity

    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.

    30 minutes (before and after the acute exercise intervention)

Secondary Outcomes (1)

  • Self-rated pain using the Visual Analogue Scale (VAS scale).

    30 minutes (before and after the acute exercise intervention)

Study Arms (2)

Acute exercise

EXPERIMENTAL

Acute exercise (bicycle at stationary cycle).

Other: Acute exercise

Rest

NO INTERVENTION

Rest (lying down or sitting in a chair) for 30 minutes, i.e. same time duration as in experimental arm.

Interventions

30 min acute exercise (bicycle at stationary cycle)

Acute exercise

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Men and women, age 18-67 years,
  • good ability to understand written and verbal information and instruction given in Swedish.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalarna University (LIVI lab)

Falun, Dalarna County, 79131, Sweden

Location

Related Publications (10)

  • Boecker H, Sprenger T, Spilker ME, Henriksen G, Koppenhoefer M, Wagner KJ, Valet M, Berthele A, Tolle TR. The runner's high: opioidergic mechanisms in the human brain. Cereb Cortex. 2008 Nov;18(11):2523-31. doi: 10.1093/cercor/bhn013. Epub 2008 Feb 21.

    PMID: 18296435BACKGROUND
  • Brumagne S, Janssens L, Knapen S, Claeys K, Suuden-Johanson E. Persons with recurrent low back pain exhibit a rigid postural control strategy. Eur Spine J. 2008 Sep;17(9):1177-84. doi: 10.1007/s00586-008-0709-7. Epub 2008 Jul 2.

    PMID: 18594876BACKGROUND
  • van den Hoorn W, Bruijn SM, Meijer OG, Hodges PW, van Dieen JH. Mechanical coupling between transverse plane pelvis and thorax rotations during gait is higher in people with low back pain. J Biomech. 2012 Jan 10;45(2):342-7. doi: 10.1016/j.jbiomech.2011.10.024. Epub 2011 Nov 10.

    PMID: 22078275BACKGROUND
  • Seay JF, Van Emmerik RE, Hamill J. Influence of low back pain status on pelvis-trunk coordination during walking and running. Spine (Phila Pa 1976). 2011 Jul 15;36(16):E1070-9. doi: 10.1097/BRS.0b013e3182015f7c.

    PMID: 21304421BACKGROUND
  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

    PMID: 20332509BACKGROUND
  • Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19.

    PMID: 28528981BACKGROUND
  • Bergstrom G, Jensen IB, Bodin L, Linton SJ, Nygren AL, Carlsson SG. Reliability and factor structure of the Multidimensional Pain Inventory--Swedish Language Version (MPI-S). Pain. 1998 Mar;75(1):101-110. doi: 10.1016/S0304-3959(97)00210-8.

    PMID: 9539679BACKGROUND
  • Tseli E, Boersma K, Stalnacke BM, Enthoven P, Gerdle B, Ang BO, Grooten WJA. Prognostic Factors for Physical Functioning After Multidisciplinary Rehabilitation in Patients With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Feb;35(2):148-173. doi: 10.1097/AJP.0000000000000669.

    PMID: 30371517BACKGROUND
  • Molander P, Dong HJ, Ang B, Enthoven P, Gerdle B. The role of pain in chronic pain patients' perception of health-related quality of life: a cross-sectional SQRP study of 40,000 patients. Scand J Pain. 2018 Jul 26;18(3):417-429. doi: 10.1515/sjpain-2018-0003.

    PMID: 29794267BACKGROUND
  • Westergren J, Sjoberg V, Vixner L, Nyberg RG, Moulaee Conradsson D, Monnier A, LoMartire R, Enthoven P, Ang BO. Acute exercise as active inference in chronic musculoskeletal pain, effects on gait kinematics and muscular activity in patients and healthy participants: a study protocol for a randomised controlled laboratory trial. BMJ Open. 2023 May 31;13(5):e069747. doi: 10.1136/bmjopen-2022-069747.

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Björn BA Äng, Assoc. Prof.

    Dalarna University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised controlled study in patients with chronic pain and healthy controls
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2018

First Posted

March 20, 2019

Study Start

December 12, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations