NCT05797311

Brief Summary

Adhesive capsulitis (AC), also known as frozen shoulder, is an insidious, painful condition of the shoulder lasting more than 3 months. This inflammatory condition causing fibrosis of the glenohumeral joint capsule is accompanied by gradual progressive stiffness and marked limitation of range of motion (typically external rotation). Patients experiencing this condition often suffer from poor quality of life due to the limitation of both the active and passive range of shoulder mobility. The prevalence of frozen shoulder is between 2-5% and is more common in women. Along with the increase in comorbidities and changes in lifestyle, the incidence of FS is increasing. However, the natural history and pathogenesis of adhesive capsulitis have not been widely studied and are still unknown. Adhesive capsulitis presents clinically as shoulder pain with progressive restricted movement, both active and passive, with normal radiographic scans of the glenohumeral joint. Classically, it progresses prognostically with 3 overlapping stages: pain (stage 1, lasting 2-9 months), stiffness (stage 2, lasting 4-12 months), and healing (stage 3, lasting 5-24 months). However, this is an estimated time frame and many patients may still experience symptoms after 6 years. Treatment modalities include conservative (ie, steroid injection, physiotherapy) and operative (ie, distension arthrography, manipulation under anesthesia, and arthroscopic release). Various physical therapy treatments commonly used in the treatment of adhesive capsulitis include ice pack, hot pack, transcutaneous electrical nerve stimulation and active and passive ROM exercises, joint mobilization techniques, proprioceptive neuromuscular facilitation (PNF), supervised home exercise programs, and Kinesio taping.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

March 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

March 10, 2023

Last Update Submit

February 16, 2024

Conditions

Keywords

adhesive CapsulitispainProprioceptive Neuromuscular FacilitationShoulder Stabilization Exercises

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) Evaluation

    The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to draw a line on this line to indicate where his condition is appropriate.

    Change from baseline to week 3

Secondary Outcomes (4)

  • Manual Muscle Testing

    Change from baseline to week 3

  • Joint Range of Motion

    Change from baseline to week 3

  • DASH (Arm, Shoulder and Hand Problems Questionnaire)

    Change from baseline to week 3

  • Short Form 12 (SF-12)

    Change from baseline to week 3

Study Arms (2)

PNF Group

EXPERIMENTAL

After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, additional PNF exercises were performed once a day, 5 times a week by the same Physiotherapist in the cases in the PNF group. It will be applied for a total of 3 weeks (Total of 15 sessions). 1. PNF contract-relax to subscapularis and internal rotators (7 Sec of contraction and 15 Sec of relaxation in external rotation, 5 repetitions) Followed by facilitation of D2 Flexion patterns for 5 repetitions. 2. PNF all scapular patterns with Rhythmic initiation and repeated contractions Technique .

Other: Proprioceptive Neuromuscular Facilitation (PNF)

Stabilization Group

OTHER

After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, stabilization exercises were performed by the same Physiotherapist once a day, 5 times a week, for a total of 5 times a week. It will be applied for 3 weeks (Total of 15 sessions). 1. scapular stabilization exercises 2. stabilization exercise for the shoulder joints. In all the exercises, the subjects maintained the position for 10 seconds, and they took a rest for 3 seconds. Ten repetitions was considered one set, and the subjects conducted three sets. A break of 3 minutes was given between each set.

Other: Shoulder Stabilization Exercises

Interventions

Proprioceptive Neuromuscular Facilitation (PNF) techniques are a therapeutic exercise approach developed based on functional activities in daily life. At the stage of regaining movement and function, it creates models similar to functional activities.

PNF Group

Scapular stabilization exercise and stabilization exercise for the shoulder joints

Stabilization Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20- 65 years diagnosed with unilateral Stage II adhesive capsulitis by magnetic resonance imaging
  • Shoulder pain persisting for at least 3 months
  • VAS pain score equal to or greater than 5/10
  • Patients who agreed to participate in the study

You may not qualify if:

  • \- Receiving physical therapy or manual therapy on the same shoulder within 1 year
  • Having mental and cognitive problems,
  • Patients who have undergone surgical procedure/injection/manipulation to the shoulder joint for any reason
  • Neurological disorders that affect shoulder function during daily activities
  • Pain or discomfort in the cervical spine, elbow, wrist, or hand
  • Other pathological conditions concerning the shoulder (rotator cuff tear, tendinitis, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University Health Science

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

  • Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.

    PMID: 31475043BACKGROUND
  • Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.

    PMID: 29992159BACKGROUND
  • Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.

    PMID: 33326025BACKGROUND
  • Barbosa F, Swamy G, Salem H, Creswell T, Espag M, Tambe A, Clark D. Chronic adhesive capsulitis (Frozen shoulder): Comparative outcomes of treatment in patients with diabetes and obesity. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):265-268. doi: 10.1016/j.jcot.2018.02.015. Epub 2018 Feb 25.

    PMID: 30828190BACKGROUND
  • Kraal T, Visser C, Sierevelt I, Beimers L. How to treat a frozen shoulder? A survey among shoulder specialists in the Netherlands and Belgium. Acta Orthop Belg. 2016 Mar;82(1):78-84.

    PMID: 26984658BACKGROUND
  • Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.

    PMID: 20110457BACKGROUND
  • Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491.

    PMID: 31789299BACKGROUND
  • Balci NC, Yuruk ZO, Zeybek A, Gulsen M, Tekindal MA. Acute effect of scapular proprioceptive neuromuscular facilitation (PNF) techniques and classic exercises in adhesive capsulitis: a randomized controlled trial. J Phys Ther Sci. 2016 Apr;28(4):1219-27. doi: 10.1589/jpts.28.1219. Epub 2016 Apr 28.

    PMID: 27190456BACKGROUND
  • Park SI, Choi YK, Lee JH, Kim YM. Effects of shoulder stabilization exercise on pain and functional recovery of shoulder impingement syndrome patients. J Phys Ther Sci. 2013 Nov;25(11):1359-62. doi: 10.1589/jpts.25.1359. Epub 2013 Dec 11.

    PMID: 24396188BACKGROUND
  • Mezian K, Coffey R, Chang KV. Frozen Shoulder(Archived). 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/

    PMID: 29489251BACKGROUND

MeSH Terms

Conditions

BursitisPain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • safiye gul abat, PT

    Uskudar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 4, 2023

Study Start

March 1, 2023

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations