NCT07129356

Brief Summary

This study evaluates a 12-week Combined Rehabilitation Program (CRP) designed to reduce musculoskeletal pain and improve physical function among rural women in northern Iraq. The program integrates home-based therapeutic exercises with simple, culturally appropriate games. Sixty-six women from the Hamdaniya district, all with nearly two decades of experience in agricultural labor and chronic musculoskeletal pain in the back, neck, and limbs, participated voluntarily. The intervention includes two supervised group sessions per week at a local sports field and remote home-based sessions guided via pre-recorded videos shared through WhatsApp. Each session lasts 45 to 60 minutes and incorporates rest periods. The program is designed to strengthen weakened muscles, improve daily function, and promote social engagement among participants. Rural women engaged in long-term agricultural labor are at increased risk of chronic musculoskeletal pain, particularly in the back, neck, and limbs. What is already known on this subject:

  • Rural women engaged in long-term agricultural labor are at increased risk of chronic musculoskeletal pain, particularly in the back, neck, and limbs.
  • Home-based therapeutic exercises are widely used to manage pain and improve physical function.
  • Community-based rehabilitation programs can support better health outcomes in underserved populations. What this study adds:
  • Introduces a culturally adapted Combined Rehabilitation Program (CRP) that blends home-based exercises with traditional games in a rural Iraqi context.
  • Explores the feasibility of delivering rehabilitation through low-cost mobile technology in resource-limited environments.
  • Provides a community-based model for accessible, flexible rehabilitation tailored to the needs of rural women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable chronic-pain

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

Study Start

First participant enrolled

June 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 23, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

Muscle imbalanceChronic musculoskeletal painBack pain

Outcome Measures

Primary Outcomes (1)

  • Change in musculoskeletal pain level in the lower back, neck, upper extremities, and lower extremities.

    Pain levels will be self-reported using the Numeric Rating Scale (NRS-11), a validated 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Participants will report pain in four body regions: lower back, neck, upper extremities, and lower extremities. The method of assessment was Numeric Rating Scale (NRS-11), administered in-person and via teleconsultation.

    Baseline and Week 12

Secondary Outcomes (2)

  • Change in flexibility.

    Baseline and Week 12

  • Change in muscle strength in upper and lower extremities and trunk.

    Baseline and Week 12

Other Outcomes (2)

  • Change in Body Weight

    Baseline and Week 12

  • Change in body mass index (BMI).

    Baseline and Week 12

Study Arms (1)

Combined Rehabilitation Program (CRP) - Single Group

EXPERIMENTAL

This arm received a 12-week Combined Rehabilitation Program (CRP), consisting of both in-person field exercises and remote tele-exercises. The intervention included therapeutic exercises and culturally relevant physical games tailored to improve musculoskeletal function and reduce pain. Exercises were focused on mobility, strength, and flexibility, targeting areas of muscle weakness identified during baseline assessment.

Behavioral: Combined Exercise

Interventions

Participants engaged in a hybrid exercise program that included: In-field sessions held twice weekly at a local sports facility (45-60 minutes per session, including rest). Remote sessions delivered via pre-recorded videos through WhatsApp, with ongoing monitoring and feedback. Exercises included walking, jogging, full-body stretching, and strength training targeting the trunk, limbs, and weak muscle groups (shoulders, back, knees). The program aimed to reduce joint and muscle pain, improve strength and flexibility, and support daily functional activities. Pre- and post-intervention assessments included muscle strength (via hand dynamometer), flexibility tests, BMI, and self-reported pain using the NRS-11 scale.

Combined Rehabilitation Program (CRP) - Single Group

Eligibility Criteria

Age18 Years - 57 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study involved only female gender (N=66) women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women have experienced Musculoskeletal pain in one or more one of fourth areas of study variables which are : the upper and lower extremities, neck, and lower back.

You may not qualify if:

  • Women who suffer from other functional diseases not related to Musculoskeletal pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Physical Education and Sport Sciences

Mosul, Nineveh Governorate, 00964, Iraq

Location

Related Publications (17)

  • Mesa-Castrillon CI, Simic M, Ferreira ML, Bennell KL, Luscombe GM, Gater K, Beckenkamp PR, Michell A, Bauman A, de Luca K, Bunker S, Clavisi O, Ferreira PH. Effectiveness of an eHealth-Delivered Program to Empower People With Musculoskeletal Pain in Rural Australia: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2024 Apr;76(4):570-581. doi: 10.1002/acr.25272. Epub 2024 Jan 29.

    PMID: 37984995BACKGROUND
  • Mesa-Castrillon CI, Simic M, Ferreira ML, Hatswell K, Luscombe G, de Gregorio AM, Davis PR, Bauman A, Bunker S, Clavisi O, Knox G, Bennell KL, Ferreira PH. EHealth to empower patients with musculoskeletal pain in rural Australia (EMPoweR) a randomised clinical trial: study protocol. BMC Musculoskelet Disord. 2021 Jan 5;22(1):11. doi: 10.1186/s12891-020-03866-2.

    PMID: 33402161BACKGROUND
  • Frattali CM. National Institutes of Health, Warren Grant Magnuson Clinical Center. ASHA. 1999 Jul-Aug;41(4):46-9. No abstract available.

    PMID: 10420662BACKGROUND
  • Mesa-Castrillon CI, Beckenkamp PR, Ferreira M, Simic M, Davis PR, Michell A, Pappas E, Luscombe G, Noronha M, Ferreira P. Global prevalence of musculoskeletal pain in rural and urban populations. A systematic review with meta-analysis. Musculoskeletal pain in rural and urban populations. Aust J Rural Health. 2024 Oct;32(5):864-876. doi: 10.1111/ajr.13161. Epub 2024 Jul 4.

    PMID: 38963186BACKGROUND
  • Lombard C, Harrison C, Kozica S, Zoungas S, Ranasinha S, Teede H. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial. PLoS Med. 2016 Jan 19;13(1):e1001941. doi: 10.1371/journal.pmed.1001941. eCollection 2016 Jan.

    PMID: 26785406BACKGROUND
  • Gonzalez-Rocha A, Mendez-Sanchez L, Ortiz-Rodriguez MA, Denova-Gutierrez E. Effect Of Exercise on Muscle Mass, Fat Mass, Bone Mass, Muscular Strength and Physical Performance in Community Dwelling Older Adults: Systematic Review and Meta-Analysis. Aging Dis. 2022 Oct 1;13(5):1421-1435. doi: 10.14336/AD.2022.0215. eCollection 2022 Oct 1.

    PMID: 36186132BACKGROUND
  • Allworth I, Luscombe G, Ferreira P, Mesa-Castrillon C. Exploring participant satisfaction with an eHealth intervention for low back pain and knee osteoarthritis: Enhancing physiotherapy access in rural Australia. Musculoskelet Sci Pract. 2025 Apr;76:103252. doi: 10.1016/j.msksp.2024.103252. Epub 2025 Jan 9.

    PMID: 39805211BACKGROUND
  • Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.

    PMID: 29731662BACKGROUND
  • Bashshur RL, Shannon GW, Smith BR, Alverson DC, Antoniotti N, Barsan WG, Bashshur N, Brown EM, Coye MJ, Doarn CR, Ferguson S, Grigsby J, Krupinski EA, Kvedar JC, Linkous J, Merrell RC, Nesbitt T, Poropatich R, Rheuban KS, Sanders JH, Watson AR, Weinstein RS, Yellowlees P. The empirical foundations of telemedicine interventions for chronic disease management. Telemed J E Health. 2014 Sep;20(9):769-800. doi: 10.1089/tmj.2014.9981. Epub 2014 Jun 26.

    PMID: 24968105BACKGROUND
  • Rockwell KL, Gilroy AS. Incorporating telemedicine as part of COVID-19 outbreak response systems. Am J Manag Care. 2020 Apr;26(4):147-148. doi: 10.37765/ajmc.2020.42784.

    PMID: 32270980BACKGROUND
  • Akbar KA, Try P, Viwattanakulvanid P, Kallawicha K. Work-Related Musculoskeletal Disorders Among Farmers in the Southeast Asia Region: A Systematic Review. Saf Health Work. 2023 Sep;14(3):243-249. doi: 10.1016/j.shaw.2023.05.001. Epub 2023 May 13.

    PMID: 37818214BACKGROUND
  • Alonso Monteiro Bezerra M, Hellwig N, da Rocha Castelar Pinheiro G, Souza Lopes C. Prevalence of chronic musculoskeletal conditions and associated factors in Brazilian adults - National Health Survey. BMC Public Health. 2018 Feb 27;18(1):287. doi: 10.1186/s12889-018-5192-4.

    PMID: 29482524BACKGROUND
  • Walker-Bone K, Palmer KT. Musculoskeletal disorders in farmers and farm workers. Occup Med (Lond). 2002 Dec;52(8):441-50. doi: 10.1093/occmed/52.8.441.

    PMID: 12488514BACKGROUND
  • Osborne A, Blake C, McNamara J, Meredith D, Phelan J, Cunningham C. Musculoskeletal disorders among Irish farmers. Occup Med (Lond). 2010 Dec;60(8):598-603. doi: 10.1093/occmed/kqq146. Epub 2010 Sep 15.

    PMID: 20844056BACKGROUND
  • Hulshof CTJ, Pega F, Neupane S, Colosio C, Daams JG, Kc P, Kuijer PPFM, Mandic-Rajcevic S, Masci F, van der Molen HF, Nygard CH, Oakman J, Proper KI, Frings-Dresen MHW. The effect of occupational exposure to ergonomic risk factors on osteoarthritis of hip or knee and selected other musculoskeletal diseases: A systematic review and meta-analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury. Environ Int. 2021 May;150:106349. doi: 10.1016/j.envint.2020.106349. Epub 2021 Feb 3.

    PMID: 33546919BACKGROUND
  • Ganesh S, Chhabra D, Kumari N. The effectiveness of rehabilitation on pain-free farming in agriculture workers with low back pain in India. Work. 2016 Oct 17;55(2):399-411. doi: 10.3233/WOR-162403.

    PMID: 27689586BACKGROUND
  • Fathe MA, Hasan MS, Karash SJ. The Effectiveness of a Rehabilitative Program on the Cervical and Lumbar Pain Relief for Rural Women. Annals of Applied Sport Science. 1 martie 2022;10(1):1-8. https://doi.org/10.52547/aassjournal.985

    BACKGROUND

MeSH Terms

Conditions

Chronic PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Munib Fathe

    University of Mosul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Design: Quasi-Experimental, One-Group Pretest-Posttest Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctorate

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 19, 2025

Study Start

June 5, 2024

Primary Completion

October 15, 2024

Study Completion

November 7, 2024

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Data availability will be available on request by contact with corresponding author on email : m.a.fathi@uomsul.edu.iq

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data will be available beginning 6 months after publication and for up to 3 years. Requests will be reviewed by the study's data-sharing committee to ensure alignment with ethical standards and scientific merit.
Access Criteria
Individual Participant Data (IPD) and related supporting documentation (such as the study protocol, statistical analysis plan, and informed consent form) will be made available to qualified researchers upon reasonable request. Access will be granted to researchers affiliated with academic institutions, non-profit organizations, or other recognized research bodies for the purpose of secondary analysis, meta-analysis, or other ethically approved scientific research. Requests for access should include a clear research proposal, objectives, and a data use agreement outlining how the data will be protected and used in compliance with applicable ethical and data protection standards. To request access, researchers may contact the corresponding author via the email address provided in the publication or through the institutional contact listed in the trial registration. Data will be shared in a de-identified format to ensure participant confidentiality.
More information

Available IPD Datasets

Individual Participant Data Set (m.a.fathi@uomosul.edu.iq)Access

Locations