NCT04568915

Brief Summary

The purpose of my research is to compare the effects of dry needling and Maitland mobilization in chronic myofacial neck pain

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 25, 2020

Last Update Submit

September 25, 2020

Conditions

Myofacial PainNeck Pain

Keywords

Neck PainMyofacial Pain

Outcome Measures

Primary Outcomes (3)

  • 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).

    4 months

  • Range of Motion

    Standard Goniometer will be used.Higher score shows improvement.

    4 months

  • 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

    4 months

Study Arms (2)

Dry Needling-Group

EXPERIMENTAL

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

Other: Dry Needling

Maitland-Group

ACTIVE COMPARATOR

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

Other: Maitland Mobilization

Interventions

Dry NeedlingOTHER

TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, DN

Dry Needling-Group
Maitland MobilizationOTHER

TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, Maitland joint mobilization

Maitland-Group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah IU

Lahore, 54000, Pakistan

Location

Related Publications (8)

  • 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.

    PMID: 20091561BACKGROUND

  • 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.

    PMID: 9793695BACKGROUND

  • 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.

    PMID: 11973695BACKGROUND

  • 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.

    PMID: 26640708BACKGROUND

  • 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.

    PMID: 28666405BACKGROUND

  • 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.

    PMID: 25143704BACKGROUND

  • 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.

    PMID: 3597072BACKGROUND

  • 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.

    PMID: 23138883BACKGROUND

MeSH Terms

Conditions

Facial PainNeck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Maryam Shabbir, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

September 29, 2020

Study Start

September 15, 2019

Primary Completion

June 20, 2020

Study Completion

June 28, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)