The Efficacy of Kinesio Taping in the Treatment of Nonspecific Acute Low Back Pain

NCT04263740 | Completed DMC

• 1 other identifier: 05291519Exp
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Purpose of the study was to examine the effect of KinesioTaping (KT) on disability, fear avoidance beliefs and pain intensity in patients with acute non-specific LBP. Materials and Methods: Seventy-eight patients were randomized to an experimental group that received traditional physical therapy plus KT and a control group that received traditional physical therapy alone. Interventions were administered twice a week for four weeks. Assessment tools used were; RMDQ for disability, FABQ for fear-avoidance beliefs and NPRS for pain intensity.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• Disability

  Disability was evaluated with the Ronald-Morris Disability Questionnaire (RMDQ). RMDQ is a patient reported outcome measure that is composed of 24 yes/no questions to assess functional status and disability in patients with low back pain. RMDQ scores can range from 0, the highest functional status indicating no disability, to 24, the lowest functional status indicating maximum disability. Patients were asked to mark the sentences that describe them at the time of evaluation.

  changes at five points of time, at baseline (W0, before interventions), at the end of the first week (W1), at the end of the second week (W2), at the end of the third week (W3) and at the end of the fourth week (W4).

Secondary Outcomes (2)

• Fear avoidance beliefs questionnaire (FABQ)

  changes at five points of time, at baseline (W0, before interventions), at the end of the first week (W1), at the end of the second week (W2), at the end of the third week (W3) and at the end of the fourth week (W4).

• Assessment of Pain

  changes at five points of time, at baseline (W0, before interventions), at the end of the first week (W1), at the end of the second week (W2), at the end of the third week (W3) and at the end of the fourth week (W4).

Study Arms (2)

Kinesio Taping plus Traditional Physical Therapy

EXPERIMENTAL

Kinesio Taping plus Traditional physical therapy

Procedure: Kinesio Taping; Procedure: Traditional Physical therapy

Traditional Physical Therapy

OTHER

Traditional physical therapy was in the form of patient education, manual therapy and therapeutic exercises.

Procedure: Traditional Physical therapy

Interventions

Kinesio Taping PROCEDURE

Taping for 3 days every week and two sessions of PT twice a week. The PI also instructed the patient to inform him if the tape gets off or become loose. KT was removed after 72 hours, and then reapplied after a few days rest to allow the skin to recover and to avoid skin irritation. The patient was instructed to refrain from getting the tape wet for 30 to 45 minutes after application to allow for better adherence. Patients were also instructed to be careful during dressing and undressing so the tape does not get caught with their clothes if the edges of the tape get slightly loose. No physical therapy treatment or taping was provided during the rest period except for the prescribed home exercise program. Patients in both groups received the same traditional physical therapy treatment two times a week.

Kinesio Taping plus Traditional Physical Therapy

Traditional Physical therapy PROCEDURE

Traditional physical therapy was in the form of patient education, manual therapy and therapeutic exercises. Patient education focused on the natural history of the condition and its favorable prognosis, positive thinking, and encouragement of activity participation. Patient education was delivered through one-on-one discussion by the principal investigator.

Kinesio Taping plus Traditional Physical Therapy; Traditional Physical Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders, age between 18 and 75.
• Primary complaint of pain in the lower back located between the costal margins and the gluteal folds, less than 4 weeks in duration with or without leg pain but symptoms not distal to the knee.
• A new episode of low back pain. This is defined as an episode which was preceded by a period of at least one month without low back pain where the participant was not consulting a health care practitioner or taking medication for their low back pain.
• Pain of sufficient intensity to interfere with patient's daily activities and function. A minimum pain intensity of 3 on the numerical pain rating scale to allow room for change, as the MCID for the NPRS is 2 points. A minimal score of 4 on the RMDQ will also be required as patients with scores under 4 and over 20 may not show meaningful change over time. NPRS and RMDQ were used to determine such criteria.
• Ability to communicate with English language which is important to complete the questionnaires successfully.
• Lumbar spine hypomobility. This was determined through palpation by applying postero-anterior pressure by the tips of the thumbs against the spinous processes of all segments of the lumbar spine. Three oscillatory postero-anterior movements were performed at each level. Through comparison of quality and range of movements at each level, the physical therapist can determine which segments are stiff or hypomobile and the quality of the end feel.

You may not qualify if:

• Patients with a diagnosis of severe degenerative and stenotic conditions which make spinal manipulative therapy contraindicated.
• known or suspected serious spinal pathology (metastatic tumors, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture, dislocations/sublaxations).
• Nerve root compromise evidenced by at least two of the following (a) myotomal weakness, (b) dermatomal or widespread sensory loss, (c) hypo or hyper-reflexia of the lower limb reflexes. Examination of sensation, reflexes and motor power were used to identify such criteria.
• Adverse skin reactions to Kinesio taping.
• RMDQ score of less than 4 or more than 20.
• NPRS of less than 3.
• Patients taking NSAIDs.
• Patients currently receiving physical therapy or any form of manual therapy.
• Previous spinal surgery.
• Patients with contraindications to manual therapy or therapeutic exercises.

Sponsors & Collaborators

• Rocky Mountain University of Health Professions: lead
• Nova Southeastern University: collaborator

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding the physical therapist (the principal investigator) who provided interventions to both groups in the study to the type of intervention was not feasible. Blinding the principal investigator to the assessment process was possible by using another physical therapist who conducted all measurements. Blinding the assessor to subject's group assignment was done to ensure unbiased ascertainment of outcomes. Randomization also served to reduce the risk of selection bias by the principal investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of orthopedic PT

Model Details: This study followed a prospective experimental pretest-posttest control group randomized design with repeated measures. Two groups were included in this study, an experimental group and a control group.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 11, 2020
• Study Start: July 1, 2015
• Primary Completion: April 28, 2016
• Study Completion: April 28, 2016
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: upon approval for 10 years
• Access Criteria: only for meta analysis and additional research