Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
Primary Purpose
Trigger Points
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Thoracic manipulation
conventional pt protocol
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Points focused on measuring Trigger Area
Eligibility Criteria
Inclusion Criteria:
- Age between 18 to 30 years
- Participants presented with interscapular pain
- Forward head posture with active trigger points in rhomboid muscle
- Segmental hypomobility in upper thoracic identified with positive springing test
Exclusion Criteria:
- Participants who demonstrated contraindication to manipulation
- Open wounds or Trauma to the area which occurred less than two months prior treatment
- Any neurological compromise
- Mid scapular pain due to degenerative process or osteoporosis
Sites / Locations
- Women Institute of Rehabilitation Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I Experimental: thoracic manipulation
Group II Control
Arm Description
The experimental group will receive thoracic manipulation along with conventional pt protocol.
this group of participant will receive Conventional physical therapy protocol
Outcomes
Primary Outcome Measures
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline and after 3 weeks
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline and after 3 weeks
Pain pressure threshold
It is measured with the help of an instrument called Algometer. The readings of Algometer are both in pounds and kilograms and it gauges the pressure at which patient feels pain.
Pain pressure threshold
It is measured with the help of an instrument called Algometer. The readings of Algometer are both in pounds and kilograms and it gauges the pressure at which patient feels pain.
Thoracic ROM
A thoraxic range of motion (TROM) inclinometer will be use to assess thoracic range of motion in flexion and extension.. Participants will be seated or standing upright and asked to actively move their trunk in forward and backward direction
Thoracic ROM
A thoraxic range of motion (TROM) inclinometer will be use to assess thoracic range of motion in flexion and extension.. Participants will be seated or standing upright and asked to actively move their trunk in forward and backward direction
Secondary Outcome Measures
Neck Disability Index (NDI)
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50. It is measured at Baseline before Intervention and after end of treatment session that is 3 weeks
Neck Disability Index (NDI)
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50. It is measured at Baseline before Intervention and after end of treatment session that is 3 weeks
Full Information
NCT ID
NCT04179214
First Posted
November 25, 2019
Last Updated
January 1, 2020
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04179214
Brief Title
Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
Official Title
Effects of Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
This study intends to determine the effects of thoracic manipulation on pressure pain sensitivity in patients with rhomboid active trigger points.
Detailed Description
This is a single blinded controlled trial and will be conducted at physiotherapy clinic of women institute of rehabilitation sciences Abbottabad. The "screw" manipulation is a fairly aggressive manipulative technique in which the transverse processes are forced into a posterior to anterior direction Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 30 in thoracic manipulation group and 30 in conventional physiotherapy protocol group by sealed envelope method. Both groups will receive conventional physiotherapy protocol (manual pressure release technique and muscle imbalances exercises) for rhomboid trigger points in common and the experimental group will receive thoracic manipulation in addition to conventional protocol.
Assessment will be done on baseline and after 3 weeks. Data will be analyzed on SPSS version 21.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Points
Keywords
Trigger Area
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
Masking
Participant
Masking Description
This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I Experimental: thoracic manipulation
Arm Type
Experimental
Arm Description
The experimental group will receive thoracic manipulation along with conventional pt protocol.
Arm Title
Group II Control
Arm Type
Active Comparator
Arm Description
this group of participant will receive Conventional physical therapy protocol
Intervention Type
Other
Intervention Name(s)
Thoracic manipulation
Intervention Description
Session will be performed twice a week for a three week period if a pop sound occurred then the therapist moved on next procedure ,if not subject will be repositioned and technique will performed again. This procedure will be performed for maximum of two attempts. Approximately 3 minutes of time is required to complete thrust manipulation subjects assigned to thrust manipulation also received general exercise program and manual pressure release technique as the control group. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.
Intervention Type
Other
Intervention Name(s)
conventional pt protocol
Intervention Description
This group will receive manual pressure release technique along with general exercises program. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.
Primary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline and after 3 weeks
Time Frame
Baseline
Title
Numeric pain rating scale (NPRS)
Description
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline and after 3 weeks
Time Frame
post 3 weeks
Title
Pain pressure threshold
Description
It is measured with the help of an instrument called Algometer. The readings of Algometer are both in pounds and kilograms and it gauges the pressure at which patient feels pain.
Time Frame
baseline
Title
Pain pressure threshold
Description
It is measured with the help of an instrument called Algometer. The readings of Algometer are both in pounds and kilograms and it gauges the pressure at which patient feels pain.
Time Frame
post 3 weeks
Title
Thoracic ROM
Description
A thoraxic range of motion (TROM) inclinometer will be use to assess thoracic range of motion in flexion and extension.. Participants will be seated or standing upright and asked to actively move their trunk in forward and backward direction
Time Frame
Baseline
Title
Thoracic ROM
Description
A thoraxic range of motion (TROM) inclinometer will be use to assess thoracic range of motion in flexion and extension.. Participants will be seated or standing upright and asked to actively move their trunk in forward and backward direction
Time Frame
post 3 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50. It is measured at Baseline before Intervention and after end of treatment session that is 3 weeks
Time Frame
Baseline
Title
Neck Disability Index (NDI)
Description
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50. It is measured at Baseline before Intervention and after end of treatment session that is 3 weeks
Time Frame
post 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 to 30 years
Participants presented with interscapular pain
Forward head posture with active trigger points in rhomboid muscle
Segmental hypomobility in upper thoracic identified with positive springing test
Exclusion Criteria:
Participants who demonstrated contraindication to manipulation
Open wounds or Trauma to the area which occurred less than two months prior treatment
Any neurological compromise
Mid scapular pain due to degenerative process or osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women Institute of Rehabilitation Sciences
City
Abbottabad
State/Province
KPK
ZIP/Postal Code
22010
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11514816
Citation
Schiller L. Effectiveness of spinal manipulative therapy in the treatment of mechanical thoracic spine pain: a pilot randomized clinical trial. J Manipulative Physiol Ther. 2001 Jul-Aug;24(6):394-401. doi: 10.1067/mmt.2001.116420.
Results Reference
background
PubMed Identifier
17996549
Citation
Ruiz-Saez M, Fernandez-de-las-Penas C, Blanco CR, Martinez-Segura R, Garcia-Leon R. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2007 Oct;30(8):578-83. doi: 10.1016/j.jmpt.2007.07.014.
Results Reference
background
PubMed Identifier
21979312
Citation
Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
Results Reference
background
PubMed Identifier
9200048
Citation
Nilsson N, Christensen HW, Hartvigsen J. The effect of spinal manipulation in the treatment of cervicogenic headache. J Manipulative Physiol Ther. 1997 Jun;20(5):326-30.
Results Reference
background
PubMed Identifier
17341509
Citation
Cleland JA, Glynn P, Whitman JM, Eberhart SL, MacDonald C, Childs JD. Short-term effects of thrust versus nonthrust mobilization/manipulation directed at the thoracic spine in patients with neck pain: a randomized clinical trial. Phys Ther. 2007 Apr;87(4):431-40. doi: 10.2522/ptj.20060217. Epub 2007 Mar 6.
Results Reference
background
PubMed Identifier
34410234
Citation
Haleema B, Riaz H. Effects of thoracic spine manipulation on pressure pain sensitivity of rhomboid muscle active trigger points: A randomized controlled trial. J Pak Med Assoc. 2021 Jul;71(7):1720-1724. doi: 10.47391/JPMA.02-256.
Results Reference
derived
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Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
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