STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke

NCT01062308 | Completed Phase 3 Results DMC

• 2 other identifiers: Jeyaraj PandianCMC/NEU/COP/JDP/2009/001
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief Summary

Background and Rationale: The most commonly seen disabilities in stroke patients are shoulder injuries such as shoulder pain, glenohumeral subluxation, spasticity of shoulder muscles, soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome. Taping is widely used in the field of rehabilitation as both means of treatment and prevention of sports related injuries. Scarce information is available regarding the use of shoulder taping in preventing shoulder injuries in stroke patients. Aims: To find out the effectiveness of taping technique with conventional treatment versus sham taping and conventional treatment in prevention of shoulder injuries in patients with acute stroke. Hypothesis: Taping technique with conventional treatment will be superior to conventional treatment alone in preventing shoulder injuries in patients with acute stroke. Methods Research setting: Stroke unit, department of Neurology, Christian Medical College (CMC) Ludhiana, Punjab, India and College of Physiotherapy, CMC Ludhiana. Study design: prospective, randomized, outcome blinded trial (PROBE design). Study period: Prospective for 18 months from May 2009 All stroke patients with upper limb weakness within 48 hours after the ictus and with Brunnstrom's stage of recovery 1 and 2 will be included in the study. Patients will be randomized into two groups using lottery method. The treatment arm group(Group I) include shoulder taping with conventional techniques that is(positioning, handling technique and passive range of motion exercises) and the control arm (Group II) include sham taping with conventional techniques with sham taping. A total of 80 patients in each group will be included. The plastic micropore and elastic adhesive tape will be used for taping the affected shoulder. The sham taping will be done using the same tapes but without stretching the concerned muscles and joints. The tapes will be changed every 3 days and will remain for 14 days. The outcome measures are as follows; Primary: Pain: Visual Analog Scale and Activities of daily living: Shoulder Pain and Disability Index (SPADI); Secondary: Range of motion: using a Goniometer. The outcome will be assessed by an independent physiotherapist who will be blinded to the clinical details. Patients will be followed-up at 14 days and 30 days. Statistical analyses will be done using SPSS software version 16.

Conditions

Stroke; Shoulder Injury

Keywords

Stroke; Taping; Pain; Shoulder Injury

Outcome Measures

Primary Outcomes (1)

• Pain: Visual Analog Scale

  Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 ("No Pain") to 100 ("Worst Pain Imaginable") Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability

  14 days and 30 days

Secondary Outcomes (1)

• Passive Range of Motion (ROM)

  14 days and 30 days

Study Arms (2)

Taping

EXPERIMENTAL

The tri-pull method of taping was used.Taping was initiated by first applying three, two-inch wide and approximately ten-inch long, pieces of elastic adhesive tape strips. The first strip was applied from the mid-humerus deltoid tuberosity across the scapula. The second strip was applied from the deltoid tuberosity across the clavicle to the mid-clavicle, but before the supra-sternal notch. The third strip was placed from the deltoid tuberosity over the acromion process to the neck.

Procedure: Taping and Sham Taping

Sham Taping

ACTIVE COMPARATOR

This was done using the same tapes. Three strips of tapes were applied in same position without repositioning the joint. All other Physiotherapy measures like positioning, handling technique and range of motion exercises were equally done for both the groups.

Procedure: Sham Taping

Interventions

Taping and Sham Taping PROCEDURE

Taping shoulder with Hospiplast tape. Taping the shoulder after acute stroke to prevent shoulder injury and pain. Taping the shoulder after acute stroke and compare with sham taping group. Treatments: 1. Positioning technique 2. Handling technique 3. Range of motion exercises 4. Taping technique

Also known as: Shoulder Taping in Stroke

Taping

Sham Taping PROCEDURE

Shoulder Taping for 14 days which will be changed after every 3 days.

Sham Taping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke patients both ischemic and hemorrhagic with upper limb weakness within 48 hours after the ictus
• Age over 18 years
• Brunnstrom's stage of recovery 1 and 2
• Patients willing to participate in the study

You may not qualify if:

• Patients with Glasgow coma scale of \<7
• Patients on ventilator
• Uncooperative patients
• Patients having previous history of shoulder injury
• Patients with Wernicke's aphasia
• Patients having previous history of shoulder pain
• Any previous history of skin allergy to tape

Sponsors & Collaborators

• Christian Medical College and Hospital, Ludhiana, India: lead
• Uppal Neuro Hospital: collaborator
• Heart and Brain Center, Guntur, Andhra Pradesh, India: collaborator

Study Sites (2)

Christian Medical College

Ludhiana, Punjab, 141008, India

Location

Jeyaraj D Pandian

Ludhiana, Punjab, 141008, India

Location

Related Publications (1)

• Pandian JD, Kaur P, Arora R, Vishwambaran DK, Toor G, Mathangi S, Vijaya P, Uppal A, Kaur T, Arima H. Shoulder taping reduces injury and pain in stroke patients: randomized controlled trial. Neurology. 2013 Feb 5;80(6):528-32. doi: 10.1212/WNL.0b013e318281550e. Epub 2013 Jan 23.

  PMID: 23345636 DERIVED

MeSH Terms

Conditions

Stroke; Shoulder Injuries; Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Follow up period was short. Secondly, X rays of the shoulder were not done to document other shoulder injuries.

Results Point of Contact

• Title: Jeyaraj D Pandian
• Organization: Christian Medical College and Hospital, Ludhiana, Punjab, India

jeyarajpandian@hotmail.com

09915784750

Study Officials

• Jeyaraj D Pandian, MD DM FRACP

  Christian Medical College, Ludhiana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: August 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 12, 2013
• Results First Posted: March 7, 2013

Record last verified: 2013-03

Locations

IN (2)