Trigger PointsNCT04179214
Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
A study testing Thoracic manipulation and conventional pt protocol in people with Trigger Points, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study intends to determine the effects of thoracic manipulation on pressure pain sensitivity in patients with rhomboid active trigger points. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Points
- What is being tested?
- Thoracic manipulation and conventional pt protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jul 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Women Institute of Rehabilitation Sciences
Abbottabad, KPK, 22010
About this study
Official title: Effects of Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
This study intends to determine the effects of thoracic manipulation on pressure pain sensitivity in patients with rhomboid active trigger points.
Read the 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.
- Conditions
- Trigger Points
- Being tested
- Thoracic manipulation, conventional pt protocol
- Keywords
- Trigger Area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic manipulationOther
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.
conventional pt protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I Experimental: thoracic manipulation | Experimental | The experimental group will receive thoracic manipulation along with conventional pt protocol. Receives: Other: Thoracic manipulation |
| Group II Control | Active comparator | this group of participant will receive Conventional physical therapy protocol Receives: Other: conventional pt protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: post 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.
Measured: baseline
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.
Measured: post 3 weeks
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
Measured: Baseline
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
Measured: post 3 weeks
Secondary outcomes (2)
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
Measured: Baseline
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
Measured: post 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start22 Jul 2019
- Primary completion15 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Trigger PointsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179214
- Sponsor's protocol ID
- RiphahIU Bibi Haleema
- Status last verified
- Jan 2020
- First submitted
- 25 Nov 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11514816Ruiz-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.
PubMed 17996549Dunning 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.
PubMed 21979312Nilsson 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.
PubMed 9200048Cleland 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.
PubMed 17341509Haleema 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.
PubMed 34410234
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
- ClinicalTrials.gov ID
- NCT04179214
- Acronym / sponsor ID
- RiphahIU Bibi Haleema
- Conditions
- Trigger Points
- Keywords
- Trigger Area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
| Arm | Type | Receives |
|---|---|---|
| Group I Experimental: thoracic manipulation | Experimental | Other: Thoracic manipulationThe experimental group will receive thoracic manipulation along with conventional pt protocol. |
| Group II Control | Active comparator | Other: conventional pt protocolthis group of participant will receive Conventional physical therapy protocol |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic manipulationSession 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. | Other | Group I Experimental: thoracic manipulation |
| conventional pt protocolThis 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. | Other | Group II Control |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: Baseline
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)
Time frame: post 3 weeks
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
Time frame: baseline
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
Time frame: post 3 weeks
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
Time frame: Baseline
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
Time frame: post 3 weeks
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
2 secondary outcomes
Neck Disability Index (NDI)
Time frame: Baseline
Neck Disability Index (NDI)
Time frame: post 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Background: PubMed 11514816Schiller 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.
- Background: PubMed 17996549Ruiz-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.
- Background: PubMed 21979312Dunning 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.
- Background: PubMed 9200048Nilsson 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.
- Background: PubMed 17341509Cleland 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.
- Derived from this study: PubMed 34410234Haleema 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.
- Individual participant dataSharing planned: No
Related trials for Trigger Points
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic manipulation and conventional pt protocol in people with Trigger Points, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (NPRS) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179214, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.