NCT04660292

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.

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 Aug 2020

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

August 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 1, 2020

Last Update Submit

December 8, 2020

Conditions

Keywords

Neck PainManual mobilizationIsometric exerciseTriger pointsVisual analog scale

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    Its a pain rating Scale Scoring between 0-10.O means no pain 10 means worse pain

    2 months

  • 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'.

    2 months

Study Arms (2)

Study Group

EXPERIMENTAL

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.

Other: Maitland's mobilization

Control Group

ACTIVE COMPARATOR

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.

Other: Traditional Physical therapy

Interventions

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

Study Group

BASELINE TREATMENT INCLUDES TENS and Hot PACKS

Control Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah IU

Lahore, 54000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 17449984BACKGROUND
  • 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.

    PMID: 27410163BACKGROUND
  • 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.

    PMID: 28158962BACKGROUND
  • 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
  • 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.

    PMID: 26304789BACKGROUND
  • 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.

    PMID: 24261931BACKGROUND
  • 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

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maryam Shabbir, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Naveed Arshad, Mphil

    Islamabad Medical and Dental College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 9, 2020

Study Start

August 1, 2020

Primary Completion

September 30, 2020

Study Completion

October 30, 2020

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations