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Adhesive Capsulitis of ShoulderNCT06699082

Kinesiotaping With Kaltenborn Mobilization Effects on Adhesive Capsulitis Recovery.

A study testing KinesioTaping and Keltonborn Mobilization in people with Adhesive Capsulitis of Shoulder, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 60 years
Conditions the study is for
Adhesive Capsulitis of Shoulder
What is being tested?
KinesioTaping and Keltonborn Mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
29 Aug 2021to 21 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

Official title: Effects of Kinesiotaping With Kaltenborn Mobilization on the Rate of Recovery in Freezing Stage of Adhesive Capsulitis

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

Read the detailed description

Human kinematics is always in spotlight and considered as a unique feature in which shoulder joint kinematics have grabbed the attention of researchers. The complexity of the shoulder joint is evident from the literature. It is having high functional demands and wide range of motion than any other joint in the human body. It is balanced by stability and mobility provided by number of ligaments, capsule, labrum and active muscles. However sometimes this balance is disturbed that results in different musculoskeletal complaints and pathologies in which one of them is adhesive capsulitis (1).The exact cause of adhesive capsulitis remains controversial.

However calcific tendinitis, glenohumeral arthritis, acromioclavicular arthritis, dupuytrens, contractures, breast cancer, cardiac issues, autonomic neuropathy, stroke, cervical disc disorders, humeral fractures, hypoadrenalism, Parkinson's disease are some of the known causes (7). It can also occur as a sequalae of osteoarthritis, rheumatoid arthritis or joint dislocation and fracture (8). The evaluation of adhesive capsulitis starts from a thorough history and proceeding towards physical examination, clinical tests and radiographic techniques. The patient usually recalls a mild trauma or accident that has caused damage to the shoulder joint, as well as limited range of motion especially external rotation, sleep disturbance and pain on insertion of deltoid and unable to perform overhead activities (9). Physical examination exposes loss of natural swing of arm. Scapular dyskinesis is also noted in some cases. shoulder joint may be painful to touch and muscle atrophy can be present. Loss of ROM is seen (9). Fasting blood sugar is performed in patients having diabetes mellitus. Since inflammation is its feature so erythrocyte sedimentation rate is suggested. Some special tests are also positive in this condition that are Neer impingement sign and Hawkin's-Kneddy. These tests are positive due to capsular stretch and internal impingement that occurs in this condition simultaneously but due to adhesive capsulitis (10). Adhesive capsulitis can be diagnosed using imaging studies like radiographs, magnetic resonance imaging, arthrography, ultrasound, and nuclear medicine. Magnetic resonance imaging is considered the gold standard due to its soft tissue visualization and scanning capabilities. However, some studies suggest that it may not accurately diagnose the condition due to the similar thickness of the Page 3 of 11 (Draft) coracohumeral ligament (10 11). Rahee Mulmulay and Himanshu Pathak et al describes kinesiotaping along with Kaltenborn mobilization and Kaltenborn mobilization alone on pain, range of motion and functional disability in patients with adhesive capsulitis is effective treatment to significant improvement in terms of pain, range of motion and functional disability (12). Literature review: A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were Kinesiotaping, mobilization, Kaltenborn mobilization, adhesive capsulitis, frozen shoulder conventional physical therapy, freezing stage. The purpose of the literature review is to find out the pre-existing literature regarding the Kinesiotaping with Kaltenborn mobalization effects on adhesive capsulitis recovery. In 2017 a randomized controlled trial conducted by Rahee Mulmulay and Himanshu Pathak et al on effectiveness of kinesiotaping along with kaltenborn mobilization and kaltenborn mobilization alone on pain, range of motion and functional disability in patients with adhesive capsulitis stated that there is significance improvement in terms of pain, range of motion and functional disability (12). In 2019 a randomized controlled trial conducted by Sumit Raghav et in India on effectiveness of Mulligan versus Kaltenborn mobilization in the management of adhesive capsulitis. The results of the study showed significant improvement in terms of pain, range of motion and functional disability (13).

Being tested
KinesioTaping and Keltonborn Mobilization
Keywords
Kinesiotaping, Kaltenborn mobilization, Frozen Shoulder
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KinesioTaping and Keltonborn MobilizationOther

    Also called Conventional Therapy with Keltonborn Mobilization

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

Study groups in NCT06699082
Study groupRoleWhat they receive
Experimental Group: 1ExperimentalExperimental 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.
Receives: Other: KinesioTaping and Keltonborn Mobilization
Control Group: 2Active comparatorControl was treated with Kaltenborn mobilization AP and PA glides along with conservative treatment and Home plane exercises.
Receives: Other: KinesioTaping and Keltonborn Mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 times a week for 3 weeks

  2. 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.

    Measured: 3 times a week for 3 weeks

  3. 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.

    Measured: 3 times a week for 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2024
  2. Study start29 Aug 2021
  3. Primary completion22 Jan 2022
  4. Study completion21 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06699082
Sponsor's protocol ID
RiphahIU Neelo Gul
Status last verified
Nov 2024
First submitted
12 Sep 2024
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

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

  • 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.

    PubMed 29807717
  • 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.

    PubMed 19735563
  • 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.

    PubMed 22034118
  • 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.

    PubMed 30258826
  • 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.

    PubMed 23352186
  • 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.

    PubMed 22219239
  • 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.

    PubMed 24374758
  • 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.

    PubMed 24283550
  • 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.

    PubMed 22109326
  • 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.

  • 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).

Questions about this trial

What is this clinical trial studying?

A study testing KinesioTaping and Keltonborn Mobilization in people with Adhesive Capsulitis of Shoulder, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical pain rating scale (time frame: 3 times a week for 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06699082, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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