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Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain

Primary Purpose

Myofacial Pain, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dry Needling
Maitland Mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofacial Pain focused on measuring Neck Pain, Myofacial Pain

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral pain involving the upper trapezius and elevator muscle of the scapula;
  • Duration of pain of at least 3 months;
  • A pain intensity corresponding to at least 20 mm on a 100 mm visual analogue scale (VAS)
  • Neck pain with symptoms provoked by either neck postures or neck movement;
  • Pain localized at least in the cervical and occipital regions but not in the orofacial region;
  • Neck disability index (NDI) greater than or equal to 15 points;
  • Restricted cervical range of movements (flexion, extension, rotation, and sidebending); (i) Presence of bilateral MTrPs in upper trapezius and levator scapulae muscles

Exclusion Criteria:

  • Any signs, symptoms, or history of the following diseases:
  • Orofacial pain and temporo-mandibular disorders
  • A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury);
  • Systemic diseases such as fibromyalgia, systemic erythematous lupus, and arthritis; (d) Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia);
  • Concomitant medical diagnosis of any primary headache (tension type or migraine);
  • Unilateral neck pain;
  • Cervical spine surgery;
  • Clinical diagnosis of cervical radiculopathy or myelopathy;
  • Needle phobia;
  • History of previous physical therapy intervention for the cervical region in last 6 months.

Sites / Locations

  • Riphah IU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling-Group

Maitland-Group

Arm Description

Tens, Stretching, Strengthening(girdle), Neck Isometrics, DN

Tens Stretching, Strengthening(girdle), Neck Isometrics, Maitland joint mobilization

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale NPRS
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Range of Motion
Standard Goniometer will be used.Higher score shows improvement.
Disability
Scoring: 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 as follows: Example:16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum Detectable Change (90% confidence): 5 points or 10 %points

Secondary Outcome Measures

Full Information

First Posted
September 25, 2020
Last Updated
September 25, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04568915
Brief Title
Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain
Official Title
Comparison Between Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 28, 2020 (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
No

5. Study Description

Brief Summary
The purpose of my research is to compare the effects of dry needling and Maitland mobilization in chronic myofacial neck pain
Detailed Description
To distinguish which technique is most effective in pain reduction and range gain because in chronic cases there is involvement of fascia, muscles and joints due to prolonged stress on any of the component affecting the other. Hence, the study will help to design a treatment plan with more accurate intervention. After sample collection according to selection criteria treatment sessions will be given to both groups for 6 weeks. Data will be collected at baseline, then after 2 weeks, 4 weeks and at 8th week. Tools for data collection are Visual analogue scale, Neck Disability Index and Goniometer. For statistical analysis SPSS 22 will be used. Intra group difference will be calculated by repeated measurement ANOVA / Friedman test and inter group analysis will be done by Independent sample t test. Descriptive data will be expressed in terms of frequency and proportions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofacial Pain, Neck Pain
Keywords
Neck Pain, Myofacial Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling-Group
Arm Type
Experimental
Arm Description
Tens, Stretching, Strengthening(girdle), Neck Isometrics, DN
Arm Title
Maitland-Group
Arm Type
Active Comparator
Arm Description
Tens Stretching, Strengthening(girdle), Neck Isometrics, Maitland joint mobilization
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, DN
Intervention Type
Other
Intervention Name(s)
Maitland Mobilization
Intervention Description
TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, Maitland joint mobilization
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale NPRS
Description
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
4 months
Title
Range of Motion
Description
Standard Goniometer will be used.Higher score shows improvement.
Time Frame
4 months
Title
Disability
Description
Scoring: 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 as follows: Example:16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum Detectable Change (90% confidence): 5 points or 10 %points
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral pain involving the upper trapezius and elevator muscle of the scapula; Duration of pain of at least 3 months; A pain intensity corresponding to at least 20 mm on a 100 mm visual analogue scale (VAS) Neck pain with symptoms provoked by either neck postures or neck movement; Pain localized at least in the cervical and occipital regions but not in the orofacial region; Neck disability index (NDI) greater than or equal to 15 points; Restricted cervical range of movements (flexion, extension, rotation, and sidebending); (i) Presence of bilateral MTrPs in upper trapezius and levator scapulae muscles Exclusion Criteria: Any signs, symptoms, or history of the following diseases: Orofacial pain and temporo-mandibular disorders A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury); Systemic diseases such as fibromyalgia, systemic erythematous lupus, and arthritis; (d) Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia); Concomitant medical diagnosis of any primary headache (tension type or migraine); Unilateral neck pain; Cervical spine surgery; Clinical diagnosis of cervical radiculopathy or myelopathy; Needle phobia; History of previous physical therapy intervention for the cervical region in last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Shabbir, PHD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah IU
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20091561
Citation
Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004249. doi: 10.1002/14651858.CD004249.pub3.
Results Reference
background
PubMed Identifier
9793695
Citation
Davidoff RA. Trigger points and myofascial pain: toward understanding how they affect headaches. Cephalalgia. 1998 Sep;18(7):436-48. doi: 10.1046/j.1468-2982.1998.1807436.x.
Results Reference
background
PubMed Identifier
11973695
Citation
Borg-Stein J, Simons DG. Focused review: myofascial pain. Arch Phys Med Rehabil. 2002 Mar;83(3 Suppl 1):S40-7, S48-9. doi: 10.1053/apmr.2002.32155.
Results Reference
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PubMed Identifier
26640708
Citation
Campa-Moran I, Rey-Gudin E, Fernandez-Carnero J, Paris-Alemany A, Gil-Martinez A, Lerma Lara S, Prieto-Baquero A, Alonso-Perez JL, La Touche R. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study. Pain Res Treat. 2015;2015:327307. doi: 10.1155/2015/327307. Epub 2015 Nov 10.
Results Reference
background
PubMed Identifier
28666405
Citation
Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
Results Reference
background
PubMed Identifier
25143704
Citation
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. doi: 10.1179/108331913X13844245102034.
Results Reference
background
PubMed Identifier
3597072
Citation
Graff-Radford SB, Reeves JL, Jaeger B. Management of chronic head and neck pain: effectiveness of altering factors perpetuating myofascial pain. Headache. 1987 Apr;27(4):186-90. doi: 10.1111/j.1526-4610.1987.hed2704186.x. No abstract available.
Results Reference
background
PubMed Identifier
23138883
Citation
Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.
Results Reference
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Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain

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