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Effect of the Dry Needling and Kinesio Taping in Management of Mechanical Low Back Pain

Primary Purpose

Mechanical Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
dry needle
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring kinesio-taping, dry needling, low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with age of 18 and above with non-specific chronic low back pain.
  • Back pain of mechanical origin, apparently without a defined cause, for at least 12 weeks duration.
  • Participants had not had any physical therapy treatment in the past six months and had never used Kinesio Taping and dry needling technique.
  • Being asymptomatic, latent MTrPs in the muscle of lumbar region (pain during examination).
  • The absence of skin allergies, Palpable taut bands (if muscle accessible).
  • Recognition of usual local pain suffered by the patient pressing on the sensitive nodule on the taut bands (focally). (identification of active MTPs).
  • Painful restriction of the full range of motion on passive stretching.
  • The consent to physical examination, dry needling and kinesio taping application.

Exclusion Criteria:

  • • Severe injury in the last 12 months.

    • Previous spinal surgical intervention, neurological diseases or musculoskeletal dis-orders, pharmacological treatment at present.
    • infection, open wound, rash, decreased blood circulation in the treatment area
    • A pacemaker, or epilepsy, presence of skin diseases and pregnancy
    • Serious spinal pathologies such as a tumor, an inflammatory disease or former fracture of L1-S1, symptoms of spinal stenosis, disc protrusion or nerve root compromise and degeneration established in more than two levels
    • Subjects who had used or had prior knowledge of the Kinesio Taping and dry needling method.
    • generalized chronic pain, fibromyalgia, clinical sign of radiculopathy and peripheral nervous system diseases
    • spondylolysis with or without spondylolisthesis, arthritis or osteoporosis and Congenital or acquired deformity
    • ongoing psychiatric or somatic disease that excluded either one or both treatment alternatives

Sites / Locations

  • Adeela Asad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

interventional group

control group

Arm Description

experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.

control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.

Outcomes

Primary Outcome Measures

comparison of dry needling and kinesio taping in management of mechanical low back pain.
mechanical low back pain will be measured using Roland Morris low back questionnaire and Pain Numeric Rating scale calculated as mean score.

Secondary Outcome Measures

Quality of life in patient with mechanical low back pain
Determine the quality of life in patient with mechanical low back pain by using WHO-QOL Questionnaire in term of domain score.

Full Information

First Posted
November 11, 2020
Last Updated
July 14, 2021
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04976582
Brief Title
Effect of the Dry Needling and Kinesio Taping in Management of Mechanical Low Back Pain
Official Title
Effect of the Dry Needling and Kinesio Taping in Management of Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Low back pain (LBP) is an extremely common problem that most people experience at some point in their life. It is the leading cause of activity limitation and work absence throughout much of the world. In India, occurrence of LBP is also alarming. Nearly 60% of the population has significant back pain at some time in their life. In Brazil, spinal pain (cervical, thoracic and lumbar) was considered the second most prevalent complaint, affecting approximately 13.5% of the population. It is estimated that globally 39% of the population will have at least one episode of back pain throughout their lives. In episodes of pain greater than 12 weeks (classified as chronic lower back pain), the prognosis is unfavorable and is highly associated with high treatment costs and work absenteeism. Non-specific low back pain" [NSLBP] is defined as, low back pain that is not attributable to a recognizable or known specific pathology - bone disorder in the spine [fracture], radicular nerve compression, slipped intervertebral disk, stenosis in lumbar spine, inflammatory disorder of spine [ankylosing spondylitis], cauda equine syndrome, congenital back disorder, infection in the spine [discitis], tumour in lumbar area, osteoporosis, meningitis, Cancer, HIV, autoimmune disorder [RA].
Detailed Description
HYPOTHESIS: Null hypothesis: There is significant effects of dry needling with conventional physiotherapy treatment as compared to Kinesio Taping with conventional physiotherapy treatment. Alternate hypothesis: There is no significant effects of dry needling with conventional physiotherapy treatment as compared to Kinesio Taping with conventional physiotherapy treatment. OBJECTIVES: The aim of this study is: To determine the effects of dry needling in management of mechanical low back pain. To determine the effects of kinesio taping in management of mechanical low back pain. To determine the quality of life in patient with mechanical low back pain. To determine the varying degree of disability measure in patient with mechanical low back pain. MATERIAL AND METHODS 3.1. Study Design Study will be a randomized control trial (RCT). 3.2. Settings The study will be conducted in the Rawal General and Dental Hospital Islamabad and Al-Nafees hospital Islamabad. 3.3. Duration of Study The duration of study will be completed in 04 months after approval of synopsis. 3.4. Sample Size Thirty patients will be enrolled in the study. Patients will be divided into groups i.e; 15 patients in each group 3.5. Sampling Technique Non probability convenient sampling. 3.6. Assessment: A pre-intervention assessment will be performed to each participant before they will be randomly assigned to kinesio taping group or dry needling group with physical therapy intervention and outcome measures will be recorded before the intervention i.e; baseline assessment ,after 2 weeks of intervention and after four weeks of treatment. After treatment, patients will be performed post-intervention assessment. 3.7. INTERVENTION: Participants will be divided into two groups Group 1: control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. Group 2: experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. 3.8. Treatment plan: There will be a 4 weeks treatment plan consisting of 12 sessions. On each week 3 sessions will be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
kinesio-taping, dry needling, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be divided into two groups Group 1: control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. Group 2: experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
Masking
None (Open Label)
Masking Description
Researcher and participants both are familiar with the procedure of interventions.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interventional group
Arm Type
Experimental
Arm Description
experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
Intervention Type
Device
Intervention Name(s)
dry needle
Other Intervention Name(s)
Exercise including McKenzie exercises
Intervention Description
modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
Primary Outcome Measure Information:
Title
comparison of dry needling and kinesio taping in management of mechanical low back pain.
Description
mechanical low back pain will be measured using Roland Morris low back questionnaire and Pain Numeric Rating scale calculated as mean score.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life in patient with mechanical low back pain
Description
Determine the quality of life in patient with mechanical low back pain by using WHO-QOL Questionnaire in term of domain score.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with age of 18 and above with non-specific chronic low back pain. Back pain of mechanical origin, apparently without a defined cause, for at least 12 weeks duration. Participants had not had any physical therapy treatment in the past six months and had never used Kinesio Taping and dry needling technique. Being asymptomatic, latent MTrPs in the muscle of lumbar region (pain during examination). The absence of skin allergies, Palpable taut bands (if muscle accessible). Recognition of usual local pain suffered by the patient pressing on the sensitive nodule on the taut bands (focally). (identification of active MTPs). Painful restriction of the full range of motion on passive stretching. The consent to physical examination, dry needling and kinesio taping application. Exclusion Criteria: • Severe injury in the last 12 months. Previous spinal surgical intervention, neurological diseases or musculoskeletal dis-orders, pharmacological treatment at present. infection, open wound, rash, decreased blood circulation in the treatment area A pacemaker, or epilepsy, presence of skin diseases and pregnancy Serious spinal pathologies such as a tumor, an inflammatory disease or former fracture of L1-S1, symptoms of spinal stenosis, disc protrusion or nerve root compromise and degeneration established in more than two levels Subjects who had used or had prior knowledge of the Kinesio Taping and dry needling method. generalized chronic pain, fibromyalgia, clinical sign of radiculopathy and peripheral nervous system diseases spondylolysis with or without spondylolisthesis, arthritis or osteoporosis and Congenital or acquired deformity ongoing psychiatric or somatic disease that excluded either one or both treatment alternatives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeela Asad, m.phil
Phone
03165184758
Email
adeelaasadfmdc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asma Irshad, m.phil
Phone
03345339123
Email
asima0332@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeela Asad, m.phil
Organizational Affiliation
Rawal Institue of Health Sciences Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adeela Asad
City
Islamabad
State/Province
Federal Capital
ZIP/Postal Code
44000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeela Asad, m.phil
Phone
03165184758
Email
adeelaasadfmdc@gmail.com
First Name & Middle Initial & Last Name & Degree
Asima Irshad, ph.d
Phone
03345339123
Email
asima0332@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Effect of the Dry Needling and Kinesio Taping in Management of Mechanical Low Back Pain

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