NCT05391984

Brief Summary

The aim of this study is to compare the effects of activity versus structural oriented treatment approach on pain, range of motion, and function in diabetic patients with frozen shoulder.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

October 17, 2022

Conditions

Frozen Shoulder

Keywords

frozen shouldermanual therapyproprioceptive neuromuscular facilitationneuroplasticitydiabetes

Outcome Measures

Primary Outcomes (3)

  • NPRS for pain

    The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    4th week

  • Goniometer for range of motion

    It will be used to measure flexion, extension, abduction, adduction, and internal and external rotation of shoulder.

    4th week

  • SPADI for pain and disability

    Shoulder pain and disability index include thirteen questions measuring pain and disability on an eleven-point scale. O being no pain, difficulty and 10 being worst pain and difficulty.

    4th week

Study Arms (2)

Activity oriented

EXPERIMENTAL

Activity-oriented therapy will be given to 15 patients which will train the structures around the shoulder in different activities of daily life.

Other: Activity oriented treatment

Structural oriented

EXPERIMENTAL

Structural-oriented therapy will be given to 15 patients including a fixed sequence of physiotherapy techniques.

Other: Structural oriented treatment

Interventions

Activity oriented treatmentOTHER

15 patients will be treated with activity oriented therapy. All subjects will receive 20 therapeutic sessions, 5 times a week over the time span of 4 weeks.

Activity oriented
Structural oriented treatmentOTHER

15 patients will be treated with structural oriented therapy. All subjects will receive 20 therapeutic sessions, 5 times a week over the time span of 4 weeks.

Structural oriented

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with frozen shoulder, limited ROM, and pain in the shoulder region
  • Patients with diabetes from 10+ years

You may not qualify if:

  • History of headaches and dizziness
  • Pain and limited ROM in the cervical spine
  • Pain and limited ROM in temporomandibular joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social security hospital, Kot Lakhpat

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (10)

  • Lho YM, Ha E, Cho CH, Song KS, Min BW, Bae KC, Lee KJ, Hwang I, Park HB. Inflammatory cytokines are overexpressed in the subacromial bursa of frozen shoulder. J Shoulder Elbow Surg. 2013 May;22(5):666-72. doi: 10.1016/j.jse.2012.06.014. Epub 2012 Sep 21.

    PMID: 22999851BACKGROUND

  • Cho CH, Lee YH, Kim DH, Lim YJ, Baek CS, Kim DH. Definition, Diagnosis, Treatment, and Prognosis of Frozen Shoulder: A Consensus Survey of Shoulder Specialists. Clin Orthop Surg. 2020 Mar;12(1):60-67. doi: 10.4055/cios.2020.12.1.60. Epub 2020 Feb 13.

    PMID: 32117540BACKGROUND

  • 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

  • Abrassart S, Kolo F, Piotton S, Chih-Hao Chiu J, Stirling P, Hoffmeyer P, Ladermann A. 'Frozen shoulder' is ill-defined. How can it be described better? EFORT Open Rev. 2020 May 1;5(5):273-279. doi: 10.1302/2058-5241.5.190032. eCollection 2020 May.

    PMID: 32509332BACKGROUND

  • Klug S, Anderer P, Saletu-Zyhlarz G, Freidl M, Saletu B, Prause W, Aigner M. Dysfunctional pain modulation in somatoform pain disorder patients. Eur Arch Psychiatry Clin Neurosci. 2011 Jun;261(4):267-75. doi: 10.1007/s00406-010-0148-4. Epub 2010 Oct 6.

    PMID: 20924589BACKGROUND

  • Vartiainen N, Kirveskari E, Kallio-Laine K, Kalso E, Forss N. Cortical reorganization in primary somatosensory cortex in patients with unilateral chronic pain. J Pain. 2009 Aug;10(8):854-9. doi: 10.1016/j.jpain.2009.02.006.

    PMID: 19638329BACKGROUND

  • Horst R, Maicki T, Trabka R, Albrecht S, Schmidt K, Metel S, von Piekartz H. Activity- vs. structural-oriented treatment approach for frozen shoulder: a randomized controlled trial. Clin Rehabil. 2017 May;31(5):686-695. doi: 10.1177/0269215516687613. Epub 2017 Jan 13.

    PMID: 28081633BACKGROUND

  • Saab CY. Pain-related changes in the brain: diagnostic and therapeutic potentials. Trends Neurosci. 2012 Oct;35(10):629-37. doi: 10.1016/j.tins.2012.06.002. Epub 2012 Jul 3.

    PMID: 22763295BACKGROUND

  • 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

  • AN Y, PARK C. EFFECTS OF A DEEP LEARNING-BASED SMARTPHONE APPLICATION ON SHOULDER ABDUCTION KINEMATICS AND BRAIN ACTIVATION IN ADHESIVE CAPSULITIS: A RANDOMIZED CONTROLLED TRIAL. Journal of Mechanics in Medicine and Biology. 2021:2140076.

    BACKGROUND

MeSH Terms

Conditions

BursitisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

June 7, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)