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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04179214
Other study ID # RiphahIU Bibi Haleema
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 22, 2019
Est. completion date December 30, 2019

Study information

Verified date January 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study intends to determine the effects of thoracic manipulation on pressure pain sensitivity in patients with rhomboid active trigger points.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 30, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Thoracic manipulation
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 protocol
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.

Locations

Country Name City State
Pakistan Women Institute of Rehabilitation Sciences Abbottabad KPK

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. Epub 2007 Mar 6. — View 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. — View 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. — View Citation

Ruiz-Sáez M, Fernández-de-las-Peñas C, Blanco CR, Martínez-Segura R, García-León 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
Primary 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 post 3 weeks
Primary 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. baseline
Primary 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. post 3 weeks
Primary 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 Baseline
Primary 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 post 3 weeks
Secondary 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 Baseline
Secondary 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 post 3 weeks
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