NCT07510737

Brief Summary

This randomized controlled, single-blind, quasi-experimental study primarily aims to investigate the effects of unilateral resistance exercise applied without directly loading the affected shoulder on muscle strength and upper extremity function in individuals with frozen shoulder. Additionally, the study seeks to examine the effects on joint range of motion, quality of life, and activities of daily living. The study will be conducted among individuals diagnosed with frozen shoulder at the Physiotherapy and Rehabilitation Outpatient Clinic of Malatya Battalgazi State Hospital. The data collection process is planned to be completed between February 2026 and December 2026. Participants will be selected from the relevant population using a non-probability convenience sampling method. Individuals meeting the inclusion criteria will be enrolled after providing written informed consent. The study will be carried out in accordance with the principles of the Declaration of Helsinki. Participants will be randomly assigned to either the control or intervention group. The study will include individuals aged 18-65 years with a diagnosis of unilateral primary or secondary frozen shoulder, presenting with more than 50% restriction in at least one of the following shoulder movements compared to the unaffected side: external rotation, abduction, or flexion, and with more than 30% limitation in joint range of motion in at least two movement planes. Individuals with concomitant shoulder trauma (e.g., rotator cuff injury), bilateral shoulder involvement, acromioclavicular joint osteoarthritis, prior treatment for frozen shoulder, psychiatric disorders that may affect compliance with medical or physical therapy interventions, concomitant neurological conditions, or a Mini-Mental State Examination (MMSE) score below 24 will be excluded from the study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress71%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

March 2, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

March 2, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

Frozen shoulderCross trainingMuscle strengthFunction

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain and Functional Disability

    Participants' shoulder pain and functional disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI is a 13-item self-reported questionnaire designed to evaluate pain and functional impairment associated with shoulder dysfunction. Each item is rated on a numeric scale ranging from 0 ('no pain/no difficulty') to 10 ('worst imaginable pain/extreme difficulty requiring assistance'). The total SPADI score ranges from 0 to 100, with higher scores indicating greater pain and functional disability. The SPADI has been demonstrated to be a valid and reliable outcome measure for the assessment of individuals with frozen shoulder.

    Baseline and post-intervention (8 weeks later )

Secondary Outcomes (7)

  • Numeric Pain Rating Scale (NPRS)

    Baseline and post-intervention (8 weeks later )

  • Muscle Strength

    Baseline and post-intervention (8 weeks later )

  • Joint Range of Motion Assessment

    Baseline and post-intervention (8 weeks later )

  • Upper Extremity Function

    Baseline and post-intervention (8 weeks later )

  • Quality of Life (QoL)

    Baseline and post-intervention (8 weeks later )

  • +2 more secondary outcomes

Study Arms (2)

cross training group

Participants diagnosed with frozen shoulder will receive 20 minutes of standard physiotherapy followed by 20 minutes of cross-education intervention.

Other: Cross-Education Group

standard physical therapy group

A 40-minute standard physiotherapy program will be administered to participants diagnosed with frozen shoulder

Other: Standard Physical Therapy Group

Interventions

In the experimental group, each session will last 40 minutes, comprising 20 minutes of standard physical therapy and 20 minutes of cross-education. The standard physical therapy content will be identical to that of the control group. The cross-education program will aim to increase the internal rotation, external rotation, flexion, and abduction strength of the unaffected shoulder during immobilization. Resistance exercises will be performed at 70-80% of the one-repetition maximum (1RM) of the unaffected extremity, with loads progressively adjusted according to individual tolerance. Strengthening exercises targeting the internal rotators, external rotators, flexors, and abductors will be performed using dumbbells and therabands. Each contraction will last 3 seconds, with repetitions performed at 10-second intervals.

cross training group

The program will be applied to both groups twice weekly for eight weeks, with the experimental group additionally receiving cross-education. The control group will undergo a 40-minute standard physical therapy protocol per session, progressively structured to reduce pain and improve shoulder range of motion. During weeks 0-3, passive and active-assisted range of motion exercises, scapular mobilization, stretching, and joint mobilizations with distraction will be performed within pain limits. Between weeks 3-5, active-assisted and active exercises, stretching, joint mobilizations, and scapulothoracic strengthening will continue. During weeks 6-8, active range of motion and strengthening exercises targeting the rotator cuff and scapulothoracic muscles will be implemented within pain limits.

standard physical therapy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include patients aged 18-65 years with a diagnosis of unilateral primary or secondary frozen shoulder. Participants will be randomly assigned to either the control or intervention group.

You may qualify if:

  • Having a diagnosis of unilateral primary or secondary frozen shoulder.
  • Range of motion in external rotation, abduction, or flexion reduced by less than 50% in at least one of these directions compared to the unaffected shoulder.
  • Loss of joint range of motion exceeding 30% in at least two movement planes compared to the unaffected shoulder.
  • Aged between 18 and 65 years.

You may not qualify if:

  • Presence of a concomitant shoulder injury (e.g., rotator cuff tear).
  • Osteoarthritis in both shoulders or in the acromioclavicular joint.
  • Previous treatment for frozen shoulder.
  • Psychiatric disorders that may interfere with adherence to medical or physical therapy.
  • Presence of other neurological disorders.
  • A score below 24 on the Mini-Mental State Examination (MMSE).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Battalgazi Devlet Hastanesi

Malatya, Turkey (Türkiye)

RECRUITING

Related Publications (20)

  • Saldiran TC, Tanhan A, Celikel R, Dincer E. Reliability of a Visual-Cognitive Technology in Measuring Reaction Times: Associations with Age, Activity Level, and Grip Strength. J Manipulative Physiol Ther. 2025 Jul-Dec;48(6-9):789-799. doi: 10.1016/j.jmpt.2025.10.054. Epub 2025 Nov 13.

    PMID: 41236463BACKGROUND
  • Loubani K, Kizony R, Milman U, Schreuer N. Hybrid Tele and In-Clinic Occupation Based Intervention to Improve Women's Daily Participation after Breast Cancer: A Pilot Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 2;18(11):5966. doi: 10.3390/ijerph18115966.

    PMID: 34199448BACKGROUND
  • Mena-Del Horno S, Balasch-Bernat M, Louw A, Luque-Suarez A, Rodriguez-Brazzarola P, Navarro-Ledesma S, Murillo C, Duenas L, Lluch E. Is there any benefit of adding a central nervous system-focused intervention to a manual therapy and home stretching program for people with frozen shoulder? A randomized controlled trial. J Shoulder Elbow Surg. 2023 Jul;32(7):1401-1411. doi: 10.1016/j.jse.2023.02.134. Epub 2023 Mar 29.

    PMID: 37001795BACKGROUND
  • Duzgun I, Turgut E, Eraslan L, Elbasan B, Oskay D, Atay OA. Which method for frozen shoulder mobilization: manual posterior capsule stretching or scapular mobilization? J Musculoskelet Neuronal Interact. 2019 Sep 1;19(3):311-316.

    PMID: 31475938BACKGROUND
  • Yasaci Z, Celik D. Does Integration of Graded Motor Imagery Training Augment the Efficacy of a Multimodal Physiotherapy Program for Patients With Frozen Shoulder? A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Apr 1;483(4):707-716. doi: 10.1097/CORR.0000000000003252. Epub 2024 Sep 17.

    PMID: 39436270BACKGROUND
  • Lluch-Girbes E, Duenas L, Mena-Del Horno S, Luque-Suarez A, Navarro-Ledesma S, Louw A. A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial. Trials. 2019 Aug 13;20(1):498. doi: 10.1186/s13063-019-3585-z.

    PMID: 31409380BACKGROUND
  • Hendy AM, Lamon S. The Cross-Education Phenomenon: Brain and Beyond. Front Physiol. 2017 May 10;8:297. doi: 10.3389/fphys.2017.00297. eCollection 2017.

    PMID: 28539892BACKGROUND
  • Lee M, Carroll TJ. Cross education: possible mechanisms for the contralateral effects of unilateral resistance training. Sports Med. 2007;37(1):1-14. doi: 10.2165/00007256-200737010-00001.

    PMID: 17190532BACKGROUND
  • Paillard T. Cross-Education Related to the Ipsilateral Limb Activity on Monopedal Postural Control of the Contralateral Limb: A Review. Front Physiol. 2020 May 21;11:496. doi: 10.3389/fphys.2020.00496. eCollection 2020.

    PMID: 32528312BACKGROUND
  • Mortezanejad M, Roostayi MM, Daryabor A, Salemi P. The Effect of Contraction Type and Training Volume in Unilateral Exercises on Cross-Education: A Narrative Review Study. Muscle Ligaments and Tendons Journal. 2023.

    BACKGROUND
  • Mirto M, Esposito F, Iaia FM, Codella R. Cross-Education of Strength: From Theory to Practice in Contemporary Sports Rehabilitation-A Narrative Review and Clinical Implications. Sports Med Open. 2025 Nov 21;11(1):129. doi: 10.1186/s40798-025-00931-9.

    PMID: 41269443BACKGROUND
  • Frazer AK, Pearce AJ, Howatson G, Thomas K, Goodall S, Kidgell DJ. Determining the potential sites of neural adaptation to cross-education: implications for the cross-education of muscle strength. Eur J Appl Physiol. 2018 Sep;118(9):1751-1772. doi: 10.1007/s00421-018-3937-5. Epub 2018 Jul 11.

    PMID: 29995227BACKGROUND
  • Sokk J, Gapeyeva H, Ereline J, Merila M, Paasuke M. Shoulder muscle function in frozen shoulder syndrome patients following manipulation under anesthesia: a 6-month follow-up study. Orthop Traumatol Surg Res. 2013 Oct;99(6):699-705. doi: 10.1016/j.otsr.2013.04.008. Epub 2013 Aug 28.

    PMID: 23993770BACKGROUND
  • de la Serna D, Navarro-Ledesma S, Alayon F, Lopez E, Pruimboom L. A Comprehensive View of Frozen Shoulder: A Mystery Syndrome. Front Med (Lausanne). 2021 May 11;8:663703. doi: 10.3389/fmed.2021.663703. eCollection 2021.

    PMID: 34046418BACKGROUND
  • Vita F, Pederiva D, Tedeschi R, Spinnato P, Origlio F, Faldini C, Miceli M, Stella SM, Galletti S, Cavallo M, Pilla F, Donati D. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound. 2024 Sep;27(3):579-587. doi: 10.1007/s40477-024-00891-y. Epub 2024 Jun 6.

    PMID: 38844748BACKGROUND
  • Mertens MG, Meeus M, Lluch Girbes E, Duenas L, Twickler MT, Verborgt O, Struyf F. Differences in biomechanical and metabolic factors between patients with frozen shoulder and asymptomatic individuals. A cross-sectional study. Musculoskelet Sci Pract. 2024 Aug;72:102980. doi: 10.1016/j.msksp.2024.102980. Epub 2024 May 28.

    PMID: 38820869BACKGROUND
  • Rawat P, Eapen C, Seema KP. Effect of rotator cuff strengthening as an adjunct to standard care in subjects with adhesive capsulitis: A randomized controlled trial. J Hand Ther. 2017 Jul-Sep;30(3):235-241.e8. doi: 10.1016/j.jht.2016.10.007. Epub 2016 Nov 21.

    PMID: 27884497BACKGROUND
  • Griesser MJ, Harris JD, Campbell JE, Jones GL. Adhesive capsulitis of the shoulder: a systematic review of the effectiveness of intra-articular corticosteroid injections. J Bone Joint Surg Am. 2011 Sep 21;93(18):1727-33. doi: 10.2106/JBJS.J.01275. No abstract available.

    PMID: 21938377BACKGROUND
  • Kim WM, Seo YG, Park YJ, Cho HS, Lee SA, Jeon SJ, Ji SM. Effects of Different Types of Contraction Exercises on Shoulder Function and Muscle Strength in Patients with Adhesive Capsulitis. Int J Environ Res Public Health. 2021 Dec 11;18(24):13078. doi: 10.3390/ijerph182413078.

    PMID: 34948688BACKGROUND
  • Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, Akbar M, Moore L, Ronquillo JC, Murrell GAC, Rodeo SA. Frozen shoulder. Nat Rev Dis Primers. 2022 Sep 8;8(1):59. doi: 10.1038/s41572-022-00386-2.

    PMID: 36075904BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Zeynal YASACI

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Lecturer

Study Record Dates

First Submitted

March 2, 2026

First Posted

April 3, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Participant data will be securely stored by the investigators and may be shared with authorized personnel if deemed necessary, in accordance with applicable privacy regulations.

Locations