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Effects of Graston Technique in Patients With Non Specific Low Back Pain

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Graston technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Low Back Pain,Pain Numeric Rating Scale,Owestry Disability Index

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Both genders

    • Age (20-40 years)
    • Patients with non-specific backache
    • Trigger points and tender points at low back region

Exclusion Criteria:

  • • Patients with chronic diseases

    • Degenerative changes in spine
    • Open wounds around the area to be treated
    • High blood pressure
    • Diabetic neuropathy
    • Cancer (depending on the type and location)
    • Taking anti-coagulants
    • Pregnancy

Sites / Locations

  • Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA.

Outcomes

Primary Outcome Measures

PNRS
Pain Numeric Rating Scale (PNRS) scores in subjects with moderate/severe pain at baseline. *P < 0.0001 vs. baseline. Includes only subjects with baseline PNRS score of 4 to 10. Scale ranges from 0 to 10. Data are shown as mean ± 95% confidence interval. n = 329 for all visits, all with a baseline PNRS score of 4 to 10.
OSWESTRY DISABILITY INDEX
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
March 24, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04815915
Brief Title
Effects of Graston Technique in Patients With Non Specific Low Back Pain
Official Title
Effects of Graston Technique in Patients With Non Specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 5, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
Non-specific low back pain upsets individuals of all age gathering and is a most significant provider to illness load everywhere on the world. Overseeing rules prescribe emergency to locate the uncommon instances of low back pain that are brought about by actually genuine pathology, thus need demonstrative work-up or proficient arrangement, or both. Since non-specific low back pain doesn't have a known pathoanatomical cause and treatment accentuations on diminishing in agony and its meanings. To determine the impacts of Graston technique in patients with non-specific low back pain. This examination was Quasi Experimental study and on the basis of inclusion standards, 20 patients were involved. PNRS and ODI used to collect the data. Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA. The data was analyzed using SPSS 21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Low Back Pain,Pain Numeric Rating Scale,Owestry Disability Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA.
Intervention Type
Other
Intervention Name(s)
Graston technique
Intervention Description
Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA.
Primary Outcome Measure Information:
Title
PNRS
Description
Pain Numeric Rating Scale (PNRS) scores in subjects with moderate/severe pain at baseline. *P < 0.0001 vs. baseline. Includes only subjects with baseline PNRS score of 4 to 10. Scale ranges from 0 to 10. Data are shown as mean ± 95% confidence interval. n = 329 for all visits, all with a baseline PNRS score of 4 to 10.
Time Frame
2 months
Title
OSWESTRY DISABILITY INDEX
Description
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Both genders Age (20-40 years) Patients with non-specific backache Trigger points and tender points at low back region Exclusion Criteria: • Patients with chronic diseases Degenerative changes in spine Open wounds around the area to be treated High blood pressure Diabetic neuropathy Cancer (depending on the type and location) Taking anti-coagulants Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqra ZakaUllah, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27745712
Citation
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
Results Reference
background
PubMed Identifier
30967811
Citation
Koch C, Hansel F. Non-specific Low Back Pain and Postural Control During Quiet Standing-A Systematic Review. Front Psychol. 2019 Mar 22;10:586. doi: 10.3389/fpsyg.2019.00586. eCollection 2019.
Results Reference
background
PubMed Identifier
21982256
Citation
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
Results Reference
background
PubMed Identifier
29321099
Citation
Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.
Results Reference
background
PubMed Identifier
19800735
Citation
Lakke SE, Soer R, Takken T, Reneman MF. Risk and prognostic factors for non-specific musculoskeletal pain: a synthesis of evidence from systematic reviews classified into ICF dimensions. Pain. 2009 Dec 15;147(1-3):153-64. doi: 10.1016/j.pain.2009.08.032. Epub 2009 Oct 2.
Results Reference
background
PubMed Identifier
16034851
Citation
Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
Results Reference
background
PubMed Identifier
20714454
Citation
Vanwye WR. Nonspecific low back pain: evaluation and treatment tips. J Fam Pract. 2010 Aug;59(8):445-8.
Results Reference
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Effects of Graston Technique in Patients With Non Specific Low Back Pain

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