AzTrials
AzTrials

Supraspinatus TendinitisNCT03744195

Effect of Kinesotaping on Management of Supraspinatus Tendinitis

A study testing Group I Experimental Kinesotaping and Group II conventional training group in people with Supraspinatus Tendinitis, 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
Search all trials

Trial summary

Supraspinatus tendonitis is a common clinical problem that causes functional and labor disabilities. It is the most frequent cause of shoulder pain. Manual therapy is a common intervention used by physical therapist for management of supraspinatus tendonitis. Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Supraspinatus Tendinitis
What is being tested?
Group I Experimental Kinesotaping and Group II conventional training group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
15 Dec 2018to 15 May 2019
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 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both Gender / Age b/w 25-60 Shoulder Pain at rest Positive Neer's Test Positive Drop Arm Test Positive Empty Can Test Positive Hawkin's Kennedy Test

Who cannot join

  • Cervical Post op, referred pain, radiculopathy, open wound, allergy to KT

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Imran Amjad

    Islamabad, Punjab Province, 46000

Other trials in Pakistan

About this study

Supraspinatus tendonitis is a common clinical problem that causes functional and labor disabilities. It is the most frequent cause of shoulder pain. Manual therapy is a common intervention used by physical therapist for management of supraspinatus tendonitis. Joint mobilization, stretching and strengthening exercises are commonly used techniques for management of this condition. In this study KT will be added to conventional manual therapy and its efficacy will be investigated.

The study design will be Randomized Clinical Trial (RCT) that will be used to compare the effects of KT added to manual therapy for management of supraspinatus tendonitis. 38 patients will be participate in this study who will be assigned randomly (biased coin method) to experimental and control groups (19+19). The data collection will be carried out at Railway Hospital Rawalpindi. Patients with shoulder pain at rest and positive for special tests (Neer's, Empty Can, Drop Arm, Hawkin's Kennedy) will be included in this study. There is no restriction on gender and age group will be between 25 and 60 years. Patients with cervical post op, referred pain, open wounds, allergic to KT and with signs of radiculopathy will be excluded from this study. Pre and post treatment evaluation will be done using Visual Analog Scale (VAS), Shoulder Pain and Disability Index (SPADI) and goniometry. Data will be collected on 1st day, 4th day and 7th day for both groups. After data collection is completed, SPSS will be used to analyze the collected data

Read the detailed description

Shoulder pain is a very common musculoskeletal disorder affecting a large portion of population . Prevalence ranges from 6% to 26% and it is estimated that 33% of population will have one episode of shoulder pain in lifetime. Rotator cuff tendonitis is considered as most common pathology of shoulder . Supraspinatus is one of the four muscles that can cause rotator cuff tendonitis. It is a common clinical disorder that causes functional and labor disorders. It is also the most frequent cause of shoulder pain.

The origin of supraspinatus is fossa of scapula and its insertion is at superior facet on greater tuberosity of humerus. The nerve supply is at C4, C5 and C6. The main function of supraspinatus is abduction of shoulder.

Indications: Supraspinatus tendonitis present following conditions

  1. Pain and inflammation
  2. Decreased ROM
  3. Decreased strength
  4. Decreased functional activity Injury Mechanisms: Supraspinatus tendonitis is caused by extrinsic as well as intrinsic factors. Extrinsic factors include increased subacromial activity, trauma, overhead activity, soft tissue imbalance, eccentric muscle overload and glenohumeral laxity. Intrinsic factorare acromial morphology, aging, acromioclavicular arthrosis and coracoacromial ligament hypertrophy.

Kinesiotaping (KT) is widely used in clinical settings for rehabilitation of shoulder disorders . It is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion. The functioning of kinesio tap is based on following:

  1. Lifting effects of epidermis layers and papillary dermis, caused by micro-convolutions formed on the taped skin .
  2. Due to wrinkles generated by the KT, vascular networks in deep vessels under the skin are increased, reducing swelling and inflammation in injured tissues .
  3. KT contributes to pain relief by producing increased stimulation of cutaneous mechanoreceptors, and provides muscle activation.

Akbaba et. al. investigated the effects of kinesio tape in management of rotator cuff tear and found that application of KT is effective in improving pain and function but the improvement was not clinically significant . Desjardins et. al. studied the efficacy of KT for rotator cuff tendonitis and found that KT significantly improved pain free range of motion. However, it couldn't be concluded with sufficient evidence that tendonitis was reduced significantly.

Being tested
Group I Experimental Kinesotaping, Group II conventional training group
Keywords
Supraspinatus, Tendinitis, Kinesotaping
Medical subject headings
Tendinopathy

What participants receive

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

  • Group I Experimental KinesotapingOther

    For application of kinesotaping following procedure will be adopted:

    1. The skin will be cleaned properly with alcohol
    2. The first strip will be applied in Y-shape (15-20% stretch) surrounding the deltoid muscle to provide inhibition and muscle relaxation
    3. A second strip (I-shape) will be applied for functional correction (50-75% stretch), passing over the supraspinatus, trapezius, glenohumeral joint and middle deltoid Daily Strengthening Exercises (3 sets / 10~30 reps) Joint mobilization (3 sets / 60 seconds hold / 30 seconds interval) Stretching Exercises (3 sets / 30 seconds hold / 30 seconds interval

  • Group II conventional training groupOther

    Joint mobilization (3 sets / 60 seconds hold / 30 seconds interval) Stretching Exercises (3 sets / 30 seconds hold / 30 seconds interval) Strengthening Exercises (3 sets / 10~30 reps)

Study groups in NCT03744195
Study groupRoleWhat they receive
Group I Experimental KinesotapingExperimentalApplication of kinesotaping along with conventional treatment
Receives: Other: Group I Experimental Kinesotaping
Group II conventional training groupActive comparatorApplication of conventional treatment
Receives: Other: Group II conventional training group

What is being measured

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

  1. Visual Analogue scale

    Visual analogue scale (VAS) is a psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

    Measured: change from baseline.This tool is used to measure pain intensity

  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: change from baseline.This tool is used to measure pain and disability level.

Secondary outcomes (1)

  1. Goniometry

    Use to measure joint range of motion

    Measured: change from baseline.This tool is used to measure range of motion of shoulder joint

Timeline

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

  1. First posted16 Nov 2018
  2. Study start15 Dec 2018
  3. Primary completion30 Apr 2019
  4. Study completion15 May 2019

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 study
Masking
Single blind
Who is masked
Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03744195
Sponsor's protocol ID
RiphahtMahnoor Anwar
Status last verified
Aug 2019
First submitted
14 Nov 2018
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Oliveira FCL, Pairot de Fontenay B, Bouyer LJ, Desmeules F, Roy JS. Effects of kinesiotaping added to a rehabilitation programme for patients with rotator cuff tendinopathy: protocol for a single-blind, randomised controlled trial addressing symptoms, functional limitations and underlying deficits. BMJ Open. 2017 Sep 24;7(9):e017951. doi: 10.1136/bmjopen-2017-017951.

    PubMed 28947462

  • Redondo-Alonso L, Chamorro-Moriana G, Jimenez-Rejano JJ, Lopez-Tarrida P, Ridao-Fernandez C. Relationship between chronic pathologies of the supraspinatus tendon and the long head of the biceps tendon: systematic review. BMC Musculoskelet Disord. 2014 Nov 18;15:377. doi: 10.1186/1471-2474-15-377.

    PubMed 25408141

  • 3. Cubała A, Śniegocki M, Hoffman J, et al. Use of the kinesio taping method in painful shoulder syndrome. Medical and Biological Sciences2012;26:71-6

  • Aguilar-Ferrandiz ME, Castro-Sanchez AM, Mataran-Penarrocha GA, Guisado-Barrilao R, Garcia-Rios MC, Moreno-Lorenzo C. A randomized controlled trial of a mixed Kinesio taping-compression technique on venous symptoms, pain, peripheral venous flow, clinical severity and overall health status in postmenopausal women with chronic venous insufficiency. Clin Rehabil. 2014 Jan;28(1):69-81. doi: 10.1177/0269215512469120. Epub 2013 Feb 20.

    PubMed 23426563

  • Drouin JL, McAlpine CT, Primak KA, Kissel J. The effects of kinesiotape on athletic-based performance outcomes in healthy, active individuals: a literature synthesis. J Can Chiropr Assoc. 2013 Dec;57(4):356-65.

    PubMed 24302784

  • Lin JJ, Hung CJ, Yang PL. The effects of scapular taping on electromyographic muscle activity and proprioception feedback in healthy shoulders. J Orthop Res. 2011 Jan;29(1):53-7. doi: 10.1002/jor.21146.

    PubMed 20607815

  • 7. Akbaba YA, Mutlu EK, Altun S, Gümüşoğlu G, Çelik D. The effects of Kinesio Tape application with different verbal input given to with patients with rotator cuff tear. Orthopaedic Journal of Sports Medicine. 2017;5(2 suppl2):2325967117S00058.

  • Kaya DO, Baltaci G, Toprak U, Atay AO. The clinical and sonographic effects of kinesiotaping and exercise in comparison with manual therapy and exercise for patients with subacromial impingement syndrome: a preliminary trial. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):422-32. doi: 10.1016/j.jmpt.2014.03.004. Epub 2014 Aug 6.

    PubMed 25108752

  • Kim MH, Oh JS. Effects of humeral head compression taping on the isokinetic strength of the shoulder external rotator muscle in patients with rotator cuff tendinitis. J Phys Ther Sci. 2015 Jan;27(1):121-2. doi: 10.1589/jpts.27.121. Epub 2015 Jan 9.

    PubMed 25642053

  • Senbursa G, Baltaci G, Atay OA. The effectiveness of manual therapy in supraspinatus tendinopathy. Acta Orthop Traumatol Turc. 2011;45(3):162-7. doi: 10.3944/AOTT.2011.2385.

    PubMed 21765229

Questions about this trial

What is this clinical trial studying?

A study testing Group I Experimental Kinesotaping and Group II conventional training group in people with Supraspinatus Tendinitis, 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 1 inclusion and 1 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 8 Aug 2019. 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?

Visual Analogue scale (time frame: change from baseline.This tool is used to measure pain intensity). The study lists 2 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 NCT03744195, which also lists 10 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 8 Aug 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in