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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03946995
Other study ID # RiphahIU Kiran Haq
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2019
Est. completion date June 30, 2019

Study information

Verified date August 2019
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the effects dry needling and Graston technique in active myofascial trigger points on upper trapezius. Half of the study participants will receive dry needling whereas other half will receive Graston technique.


Description:

This is a single blinded randomized controlled trial, will be conducted at Rawal General & Dental Hospital, Islamabad. Both dry needling and Graston Techniques are used to release active Myofascial Trigger points with different mechanism.

Dry needling is technique in which without any medication or injection, dry needles are inserted into hyper irritable points in muscle. Graston technique is done with specially designed tools to locate knots within muscle by running the tools over the skin.

This study is planned with objectives to compare both treatment techniques on active myofascial trigger points in patients with neck pain. Effects of these will be measured on Neck Pain, Range of Motion, functional status and trigger points.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Patient with non-specific pain in neck (acute and sub-acute)

- Age: 20-40 years

- Patient agrees to use the dry needling or Graston exclusively

Exclusion Criteria:

- Patients that were using any medication to reduce the pain and/or have any effect in the skeleton muscle.

- Patient taking other treatment in the same period of research.

- Patients having malignancy, tuberculosis, spinal cord injury, neurodegenerative diseases radiculopathies and hematoma.

- Patients on anticoagulants.

- Patient with chronic neck pain.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dry Needling Group
Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed. Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points. The treatment will be continued for 2 weeks with 2 sessions per week.
Graston Technique Group
Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed. Later, lubricant will be applied to the skin, and Graston technique will be applied using instrument over the active myofascial trigger points in upper trapezius. The treatment will be continued for 2 weeks with 2 sessions per week.

Locations

Country Name City State
Pakistan Rawal General and Dental Hospital, Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. Review. — View Citation

Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980. — View Citation

Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4. — View Citation

Wang G, Gao Q, Hou J, Li J. Effects of Temperature on Chronic Trapezius Myofascial Pain Syndrome during Dry Needling Therapy. Evid Based Complement Alternat Med. 2014;2014:638268. doi: 10.1155/2014/638268. Epub 2014 Oct 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale (NPRS) Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score. Baseline
Primary Numeric Pain Rating Scale (NPRS) Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score. Post 2nd week
Primary cervical range of motion (CROM) A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction. Baseline
Primary cervical range of motion (CROM) A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction. Post 2nd week
Primary Myofascial Diagnostic Scale (MDS) It is a scale using the signs of a Myofascial trigger point as indicators to assess the extent to which the patient suffers from Myofascial Pain Syndrome.
The signs include: referred pain in the zone of reference, local twitch response, palpable taut band, and focal or spot tenderness.
Spot tenderness or soft tissue tenderness consisted of five grades or indicators: grade 0 - no tenderness = 0, grade 1 - tenderness to palpation without grimace or flinch = 1, grade 2 - tenderness with grimace and/or flinch to palpation = 2, grade 3 - tenderness with withdrawal = 3, grade 4 - withdrawal to non-noxious stimuli = 4.
The presence of a local twitch response and the presence of a palpable taut band were indicated by a score of 4 on the scale.
The presence of referred pain was indicated by a score of 5. A total score of 9 or more was indicative of active trigger points.
Baseline
Primary Myofascial Diagnostic Scale (MDS) It is a scale using the signs of a Myofascial trigger point as indicators to assess the extent to which the patient suffers from Myofascial Pain Syndrome.
The signs include: referred pain in the zone of reference, local twitch response, palpable taut band, and focal or spot tenderness.
Spot tenderness or soft tissue tenderness consisted of five grades or indicators: grade 0 - no tenderness = 0, grade 1 - tenderness to palpation without grimace or flinch = 1, grade 2 - tenderness with grimace and/or flinch to palpation = 2, grade 3 - tenderness with withdrawal = 3, grade 4 - withdrawal to non-noxious stimuli = 4.
The presence of a local twitch response and the presence of a palpable taut band were indicated by a score of 4 on the scale.
The presence of referred pain was indicated by a score of 5. A total score of 9 or more was indicative of active trigger points.
Post 2nd Week
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. 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. Post 2nd week
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