Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients

NCT ID: NCT05649774

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2023-01-25

Brief Summary

Lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. This act as a global burden and is highly prevalent in our society. This pain can result in life long disability, loss of function and mobility among individuals. The female of the society suffers from lower back pain the most because of the under lying causes, prolong standing and stooping as well as because of hormonal changes in their bodies

Detailed Description

After studying the prevalence of the lower back pain among the females of Pakistan, the investogator find the need to assess the type of their pain and find out the best way to ease their pains. The motive was to develop a treatment protocol whose effects last longer and is inexpensive for the management of lower back pain.

Moreover, the investigator decided to study that which treatment protocol is better when compared to another and what is the role of sham treatment when given to the patients.

Conditions

Lower Back Pain; Musculoskeletal Diseases or Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Myofascial Release (MFR)

The therapist will place its hands on the T12-L1 levels as well as on the sacrum. A cross handed hold will be performed along the fascia. Then for the gluteus Medius and maximus muscle, the therapist will stand facing the participant's leg and closed to the superior border of participant's pelvis. The therapist will place the palm of the hand on the anterior surface, allowing the fingers to rest on the outer fibers of the gluteal muscles stabilizing the pelvis of the participants. Allow the participant to flex its knee while applying adequate amount of stretch on the hip joint in an open pack position. Hold, wait for the release and stretch again. for tensor fascia Latae, The therapist will place several slightly adducted fingers of its one hand on the superior fibers proximal to the insertion on the anterior superior iliac crest and the thumb as well as the other fingers of the other hand on the distal muscle fibers. Hold, wait for the release and stretch again.

Group Type: ACTIVE_COMPARATOR

Therapy

Intervention Type: PROCEDURE

Only Myofascial Release will be provided

Kinesio Taping (KT)

Lumbar star correction technique was applied. 4 tape I strips will be cut. The paper from the center will be torn. The targeted area will be stretched as tolerated at the lumbar region. The therapist will apply 25% to 35% tension to the strip within the therapeutic zone over the target tissue. End the strip with no tension and activate the adhesive. For the second strip change the posture in order to change the stretch on the tissue, apply the second strip with 25% to 35% tension in the center of the tape and end with no tension. Activate the adhesive. Now flex the trunk and rotate on one side. Apply the third tape strip with 25% to 35% tension in the center of the tape. Apply the fourth tape strip with flexion and rotation on the opposite side again with 25% to 35% tension on the strip.

The tape will be changed 3 times per week.

Group Type: ACTIVE_COMPARATOR

Taping technique

Intervention Type: PROCEDURE

Only Kinesiotaping will be provided

Myofascial Release with Taping (MFKT)

Same Protocol of MFR followed by KT

Group Type: EXPERIMENTAL

Therapy with taping

Intervention Type: PROCEDURE

Myofascial release will be provided followed by Kinesiotaping

Placebo Treatment

The control group received a sham myofascial release for 40 minutes per treatment session, three times a week for three weeks. The sham myofascial release was applied by gently placing the hands over the same areas treated in the MFR group,without sliding, just enough to maintain contact for the desired time.

Group Type: SHAM_COMPARATOR

SHAM

Intervention Type: PROCEDURE

Placebo Treatment will be given

Interventions

Therapy

Only Myofascial Release will be provided

Intervention Type: PROCEDURE

Taping technique

Only Kinesiotaping will be provided

Intervention Type: PROCEDURE

Therapy with taping

Myofascial release will be provided followed by Kinesiotaping

Intervention Type: PROCEDURE

SHAM

Placebo Treatment will be given

Intervention Type: PROCEDURE

Other Intervention Names

Myofascial Release; Taping; Therapy followed by taping

Eligibility Criteria

Inclusion Criteria

• Females who were willing to participate.
• Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire.

Exclusion Criteria

• Post-menopausal women
• Females with any diagnosed co-morbidity.
• Back pain progressive to any neurological deficit
• Sustained or increased back pain with loss of appetite and unexplained weight loss accompanied with fever, nausea and chills
• With any known spinal or lower back pathology
• Tumor of the spine
• Any underlying diseases of spinal cord (i.e, ankylosing spondylosis, spondolisthesis)
• With any steroid therapy for lower back pain in the past three months
• Any inflammatory rheumatic disease
• Sensitive skin or any skin allergy or dermatological condition
• Any rehabilitative services taken for the lower back pain in the past two months
• Rejection to manual conatct

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Karachi

OTHER

Sponsor Role: lead

Responsible Party

Kiran Arshad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kiran Arshad, M.Phil

Role: PRINCIPAL_INVESTIGATOR

University of Karachi

Locations

Al-Tibri Medical college and hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

KArshad

Identifier Type: -

Identifier Source: org_study_id