NCT06699082

Brief Summary

The purpose of the study is to determine the Effects of Kinesiotaping with Kaltenborn Mobilization on Rate of Recovery in Freezing Stage of Adhesive Capsulitis. A randomized control trial was conducted at Habib physiotherapy complex Peshawar and Pak physio rehabilitation Peshawar. The sample size was 34 calculated through open-epi tool. The participants were divided into two groups each having 17 participants. The study duration was six months. Consecutive sampling technique was used for the selection of subjects for the study that fulfills the eligibility criteria was included in the study. Block randomization was used to allocate subjects into interventional and control arms of the trial. The first two patients who fulfill the criteria were allocated to interventional arm and the next two patients were allocated in control arm till completion of the sample size for both the arms. Tools used in this study are Goniometer, SPADI, NPRS. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 20

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 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

Study Start

First participant enrolled

August 29, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

September 12, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

KinesiotapingKaltenborn mobilizationFrozen Shoulder

Outcome Measures

Primary Outcomes (3)

  • Numerical pain rating scale

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults,\[1\]\[2\]\[3\] including those with chronic pain due to rheumatic diseases The 11-points of numeric pain rating scale ranges from '0' representing one with no pain, 1 to 3 with mild pain, 4 to 7 with moderate pain and 8 to 10 representing the pain extreme.

    3 times a week for 3 weeks

  • shoulder pain and disability index

    The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.

    3 times a week for 3 weeks

  • Goniometry

    A goniometer is a device that measures an angle or permits the rotation of an object to a definite position. In orthopedics, the former description applies more. The art and science of measuring the joint ranges in each joint plane are called goniometry. Goniometric measurements were obtained by aligning the goniometer arms with bony landmarks and aligning the fulcrum of the goniometer with the approximate location of the glenohumeral joint axis.

    3 times a week for 3 weeks

Study Arms (2)

Experimental Group: 1

EXPERIMENTAL

Experimental group was treated with kinesiotaping along with Kaltenborn mobilization AP and PA glides. The treatment protocol was administered in 10 reps' and 3 sets, and AP and PA glide were given. Kinesiotaping: First the deltoid area was dried and cleansed, excessive hair were trimmed, the KT was cut into Y-shape and I- shape, after that whole length of the thumb was used to stretch the tape for about 15% to 25% and then from 25% to 50%. The tape was rubbed vigorously for few seconds, heat activates glue. The whole procedure takes about 15 to 20 minutes.

Other: KinesioTaping and Keltonborn Mobilization

Control Group: 2

ACTIVE COMPARATOR

Control was treated with Kaltenborn mobilization AP and PA glides along with conservative treatment and Home plane exercises.

Other: KinesioTaping and Keltonborn Mobilization

Interventions

Experimental group was treated with kinesiotape and kaltenborn mobilization while the non experimental group was treated with conventional therapy along with kaltenborn mobilization.

Also known as: Conventional Therapy with Keltonborn Mobilization
Control Group: 2Experimental Group: 1

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders male and female.
  • Age 35-60 years.
  • Acute shoulder pain (10 to 36 weeks).
  • Patients with diabetes mellitus.
  • Referred and diagnose patients

You may not qualify if:

  • Any fracture related to the shoulder joint.
  • Post operative case and osteoporotic.
  • Shoulder with manipulation under anesthesia.
  • Steroid injection therapy
  • Diagnosed rheumatoid arthritis
  • Neurological deficits / Hemiplegics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (13)

  • Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Apr;20(3):502-14. doi: 10.1016/j.jse.2010.08.023. Epub 2010 Dec 16. No abstract available.

    PMID: 21167743BACKGROUND
  • Cohen C, Ejnisman B. Epidemiology of frozen shoulder. Shoulder stiffness: Springer; 2015. p. 21-30.

    BACKGROUND
  • Kingston K, Curry EJ, Galvin JW, Li X. Shoulder adhesive capsulitis: epidemiology and predictors of surgery. J Shoulder Elbow Surg. 2018 Aug;27(8):1437-1443. doi: 10.1016/j.jse.2018.04.004. Epub 2018 May 25.

    PMID: 29807717BACKGROUND
  • Gaspar PD, Willis FB. Adhesive capsulitis and dynamic splinting: a controlled, cohort study. BMC Musculoskelet Disord. 2009 Sep 7;10:111. doi: 10.1186/1471-2474-10-111.

    PMID: 19735563BACKGROUND
  • White D, Choi H, Peloquin C, Zhu Y, Zhang Y. Secular trend of adhesive capsulitis. Arthritis Care Res (Hoboken). 2011 Nov;63(11):1571-5. doi: 10.1002/acr.20590.

    PMID: 22034118BACKGROUND
  • Malavolta EA, Gracitelli MEC, Ribeiro Pinto GM, Freire da Silveira AZ, Assuncao JH, Ferreira Neto AA. Asian ethnicity: a risk factor for adhesive capsulitis? Rev Bras Ortop. 2018 Feb 23;53(5):602-606. doi: 10.1016/j.rboe.2018.02.004. eCollection 2018 Sep-Oct.

    PMID: 30258826BACKGROUND
  • Wang K, Ho V, Hunter-Smith DJ, Beh PS, Smith KM, Weber AB. Risk factors in idiopathic adhesive capsulitis: a case control study. J Shoulder Elbow Surg. 2013 Jul;22(7):e24-9. doi: 10.1016/j.jse.2012.10.049. Epub 2013 Jan 24.

    PMID: 23352186BACKGROUND
  • Robinson CM, Seah KT, Chee YH, Hindle P, Murray IR. Frozen shoulder. J Bone Joint Surg Br. 2012 Jan;94(1):1-9. doi: 10.1302/0301-620X.94B1.27093.

    PMID: 22219239BACKGROUND
  • Struyf F, Meeus M. Current evidence on physical therapy in patients with adhesive capsulitis: what are we missing? Clin Rheumatol. 2014 May;33(5):593-600. doi: 10.1007/s10067-013-2464-3. Epub 2013 Dec 28.

    PMID: 24374758BACKGROUND
  • Harris G, Bou-Haidar P, Harris C. Adhesive capsulitis: review of imaging and treatment. J Med Imaging Radiat Oncol. 2013 Dec;57(6):633-43. doi: 10.1111/1754-9485.12111. Epub 2013 Sep 10.

    PMID: 24283550BACKGROUND
  • Song KD, Kwon JW, Yoon YC, Choi SH. Indirect MR arthrographic findings of adhesive capsulitis. AJR Am J Roentgenol. 2011 Dec;197(6):W1105-9. doi: 10.2214/AJR.10.6099.

    PMID: 22109326BACKGROUND
  • Pathak RMaH. Effect Of Kinesiotaping Along With Kalternborn Mobilization In Patients With Sub Acute Adhesive Capsulitis. International Journal of Current Advanced Research. 2017;Vol 6(Issue 12):8489-98.

    BACKGROUND
  • Ragav S, Singh A. Comparison of Effectiveness of Mulligan ‗MWM'Technique versus Kaltenborn Mobilization Technique on Pain and End Range of Motion in Patients with Adhesive Capsulitis of Shoulder Joint: A Randomized Controlled Trial. Journal of Exercise Science & Physiotherapy Vol. 2019;15(1).

    BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Lal Gul Khan, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Control Group: Kaltenborn mobilization AP and PA glides 10 reps' x 3 sets along with conventional therapy (hot pack for 10 mins, tens for 5 mins, AROMS exercises 10 reps 2 sets). Control was treated with Kaltenborn mobilization AP and PA glides 10 reps' x 3 sets along with conventional therapy that include; hot pack for 10 mins, tens for 5 mins, AROMS exercises 10 reps 2 sets. Home plane exercises included pendulum exercise, towel stretch exercise, and finger ladder exercise, cross body adduction exercise.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental Group: kinesiotaping along with Kaltenborn mobilization AP and PA glides Experimental group was treated with kinesiotaping along with Kaltenborn mobilization AP and PA glides. The treatment protocol was administered in 10 reps' and 3 sets. AP Glide and PA Glide were applied. Kinesiotaping: First the deltoid area was dried and cleansed, excessive hair were trimmed, the KT was cut into Y-shape and I- shape was applied. The conventional therapy included; hot pacK, TENS for 5 mins and AROMS exercises 10 reps 2 sets. Home plan exercises included pendulum exercise, towel stretch exercise, finger ladder exercises and cross body adduction exercise.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2024

First Posted

November 21, 2024

Study Start

August 29, 2021

Primary Completion

January 22, 2022

Study Completion

February 21, 2022

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations