NCT05173948

Brief Summary

The objective of this study is to determine the effectiveness of Kinesio taping (KT) with Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and Supervised Exercise therapy and CPT in the management of CLBP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

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

June 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

November 23, 2021

Last Update Submit

December 29, 2021

Conditions

Keywords

Low back painChronicKinesio tapingTENSExercises

Outcome Measures

Primary Outcomes (3)

  • Numerical Pain Rating Scale

    Pain, for the Average pain intensity over the last week was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible

    Six weeks

  • Modified Oswestry low back pain disability questionnaire

    Disability were measured using the Modified Oswestry Disability Index (MODI) which is a self-rating questionnaire used to evaluate functional physical disability

    Six weeks

  • Lumbar range of motion-Modified Schober test

    Lumbar flexion range of motion were measured by using modified Schober method

    Six weeks

Study Arms (2)

Kinesio taping and Conventional Physical therapy

EXPERIMENTAL

Kinesio taping with Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy

Other: Kinesio tapingDevice: Conventional physical therapy

Conventional Physical therapy

EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy

Device: Conventional physical therapy

Interventions

Kinesio taping: The tape is measured from the sacrum to the 12th thoracic vertebra with forwarding flexion of the trunk. The base is affixed to the insertion in the resting position. The muscle is elongated and the base anchored with skin displacement. The tape is then affixed with 10% stretch paravertebrally over the muscle bundles up to T12. The tape is rubbed with the muscle in the elongated state.

Kinesio taping and Conventional Physical therapy

Transcutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform. Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region. The current intensity was increased up to the patient's perception of paraesthesia. The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles. Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks.

Conventional Physical therapyKinesio taping and Conventional Physical therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain caused by mechanical/nonspecific low back pain.
  • Degeneration of the spine and intervertebral disc.
  • The visual analog scale of pain 4 and above
  • Low back pain for at least three months

You may not qualify if:

  • Physical therapy treatment is taken in the past 6 months period
  • Previous spinal surgery with fixation
  • Structural anomalies
  • Spinal cord compression
  • Severe osteoporosis
  • Acute infections
  • Severe cardiovascular or metabolic diseases
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tabuk

Tabuk, North West, 71491, Saudi Arabia

Location

Related Publications (1)

  • Pakkir Mohamed SH, Al Amer HS, Nambi G. The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Clin Rheumatol. 2023 Jan;42(1):233-244. doi: 10.1007/s10067-022-06352-3. Epub 2022 Sep 1.

MeSH Terms

Conditions

Low Back PainBronchiolitis Obliterans SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 30, 2021

Study Start

June 15, 2019

Primary Completion

June 30, 2020

Study Completion

August 30, 2020

Last Updated

December 30, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations