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Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain

Primary Purpose

Myofascial Pain Syndrome of Neck

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Maitland's mobilization
Traditional Physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome of Neck focused on measuring Neck Pain, Manual mobilization, Isometric exercise, Triger points, Visual analog scale

Eligibility Criteria

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

Inclusion Criteria:

  • Patients age between 25-45 years old,
  • 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 2 cm on a 10 cm 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 side-bending); ---Presence of bilateral MTrPs in upper trapezius and levator scapulae muscles were included in this study.

Exclusion Criteria:

  • A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury);
  • Systemic diseases such as fibromyalgia, systemic erythematous lupus and arthritis;
  • Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia);
  • Concomitant medical diagnosis of any primary headache (tension type or migraine);
  • Cervical spine surgery; and clinical diagnosis of cervical radiculopathy or myelopathy

Sites / Locations

  • Riphah IU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

The study group was treated with Maitland mobilization and manipulation techniques including postero-anterior Maitland mobilization for C1-C2, Maitland lateral PA glide for C3-C6 and Maitland thrust manipulation for cervico-thoracic junction. Frequency of mobilization was 2 days a week for 4 weeks. While intensity of mobilization was grade 3 and 4 based on the Maitland concept.13 Time of oscillations was 2 or 3 oscillations in a second for 1 to 2 minutes.

While placebo treatment with conventional physiotherapy (active exercises-10 repetitions in all direction in pain free range, isometrics 5-10 seconds brief but maximum contraction each held for 5-16 seconds for flexors, extensors, side flexors and rotators)14 without gliding, oscillations and thrust were recommended for the control group.The placebo group was treated with baseline treatment including TENS 10 minutes and moist hot packs in sitting position for 15 minutes on cervical region in with head resting on table with a pillow.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Its a pain rating Scale Scoring between 0-10.O means no pain 10 means worse pain
Neck disability Index
Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2020
Last Updated
December 8, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04660292
Brief Title
Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain
Official Title
Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
Yes

5. Study Description

Brief Summary
Myofacial neck pain is a common musculoskeletal problem caused by presence of trigger points and local and referred pain patterns. Chronic neck pain is responsible for the involvement of joints, ligaments, fascia and connective tissue as well. The objective of this study was to assess the impacts of Maitland's mobilization in patients with myofacial chronic neck pain. Maitland's mobilization is one of the most common manual therapy approaches used by physiotherapists. Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness. In this randomized, placebo treatment controlled trial, 30 patients consecutively aged 25-45 years meeting inclusion criteria were isolated into two groups. The study group was treated with Maitland's mobilization consistently for 8 weeks while the control group got placebo treatment for a similar time frame. Visual analog Scale (VAS), Neck disability index (NDI) and cervical range of motion (ROM) questionnaire was filled by patients before, intermediate and after the intervention to evaluate the severity of pain, functional ability and range of motion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome of Neck
Keywords
Neck Pain, Manual mobilization, Isometric exercise, Triger points, Visual analog scale

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
The study group was treated with Maitland mobilization and manipulation techniques including postero-anterior Maitland mobilization for C1-C2, Maitland lateral PA glide for C3-C6 and Maitland thrust manipulation for cervico-thoracic junction. Frequency of mobilization was 2 days a week for 4 weeks. While intensity of mobilization was grade 3 and 4 based on the Maitland concept.13 Time of oscillations was 2 or 3 oscillations in a second for 1 to 2 minutes.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
While placebo treatment with conventional physiotherapy (active exercises-10 repetitions in all direction in pain free range, isometrics 5-10 seconds brief but maximum contraction each held for 5-16 seconds for flexors, extensors, side flexors and rotators)14 without gliding, oscillations and thrust were recommended for the control group.The placebo group was treated with baseline treatment including TENS 10 minutes and moist hot packs in sitting position for 15 minutes on cervical region in with head resting on table with a pillow.
Intervention Type
Other
Intervention Name(s)
Maitland's mobilization
Intervention Description
Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.It has Five grades
Intervention Type
Other
Intervention Name(s)
Traditional Physical therapy
Intervention Description
BASELINE TREATMENT INCLUDES TENS and Hot PACKS
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Its a pain rating Scale Scoring between 0-10.O means no pain 10 means worse pain
Time Frame
2 months
Title
Neck disability Index
Description
Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.
Time Frame
2 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: Patients age between 25-45 years old, 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 2 cm on a 10 cm 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 side-bending); ---Presence of bilateral MTrPs in upper trapezius and levator scapulae muscles were included in this study. Exclusion Criteria: A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury); Systemic diseases such as fibromyalgia, systemic erythematous lupus and arthritis; Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia); Concomitant medical diagnosis of any primary headache (tension type or migraine); Cervical spine surgery; and clinical diagnosis of cervical radiculopathy or myelopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Shabbir, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naveed Arshad, Mphil
Organizational Affiliation
Islamabad Medical and Dental College
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
17449984
Citation
Hsieh YL, Kao MJ, Kuan TS, Chen SM, Chen JT, Hong CZ. Dry needling to a key myofascial trigger point may reduce the irritability of satellite MTrPs. Am J Phys Med Rehabil. 2007 May;86(5):397-403. doi: 10.1097/PHM.0b013e31804a554d.
Results Reference
background
PubMed Identifier
27410163
Citation
Leon-Hernandez JV, Martin-Pintado-Zugasti A, Frutos LG, Alguacil-Diego IM, de la Llave-Rincon AI, Fernandez-Carnero J. Immediate and short-term effects of the combination of dry needling and percutaneous TENS on post-needling soreness in patients with chronic myofascial neck pain. Braz J Phys Ther. 2016 Jul 11;20(5):422-431. doi: 10.1590/bjpt-rbf.2014.0176.
Results Reference
background
PubMed Identifier
28158962
Citation
Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.
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
background
PubMed Identifier
26304789
Citation
Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
Results Reference
background
PubMed Identifier
24261931
Citation
Clewley D, Flynn TW, Koppenhaver S. Trigger point dry needling as an adjunct treatment for a patient with adhesive capsulitis of the shoulder. J Orthop Sports Phys Ther. 2014 Feb;44(2):92-101. doi: 10.2519/jospt.2014.4915. Epub 2013 Nov 21.
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
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Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain

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