NCT05213871

Brief Summary

Mechanical neck pain has become a major health problem recently, affecting around one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years causing pain and functional deficits. No study has been conducted before to investigate the effect of Instrument assisted soft tissue mobilization (IASTM) with mechanical neck pain on university students involved in distance learning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

January 16, 2022

Last Update Submit

March 24, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity assessment

    Assessing the change in pain intensity via using visual analogue scale which will be used to examine pain intensity. It consists of a continuous 10 cm line. The patient will be instructed to place a vertical mark on the line to indicate his/her pain, ranging from no pain or discomfort (0), to the worst pain he/she could possibly feel . Using the visual analogue scale allows the patient freedom to record and not restricting him by numbers.

    at baseline and after 4 weeks of intervention

  • Neck disability index

    Assessing the change in neck disability via using Neck disability index which is is a self-reported outcome measure which is commonly used to determine the perceived disability in patients with neck pain. It consists of 10 items; 7 related to activities of daily living, (ADL), 2 related to pain, and 1 related to concentration. Each item is scored from 0-5 and the total score is expressed as percentage, with higher scores corresponding to greater disability.

    at baseline and after 4 weeks of intervention

  • Muscle pressure intensity

    Assessing the change in Muscle pressure intensity via using Pressure Algometer which is a handheld device that applies a manual pressure stimulus to assess pressure intensity. It has been broadly used and validated. A pressure threshold algometer will be used to measure the pressure pain threshold of a Trigger points of the upper trapezius and levator scapulae muscle before and aftertreatment.

    at baseline and after 4 weeks of intervention

Study Arms (2)

IASTM group

EXPERIMENTAL

Group (A) will receive IASTM on the right upper trapezius and levator scapulae twice a week for four weeks in addition to a postural correction program.

Other: Instrument-assisted soft tissue mobilizationOther: Postural correction exercises (PCE)

myofascial release group

EXPERIMENTAL

Group (B) will receive a myofascial release on the right upper trapezius and levator scapulae twice a week for four weeks in addition to the postural correction program.

Other: Myofascial release therapyOther: Postural correction exercises (PCE)

Interventions

For IASTM, the subject will be seated in a comfortable position. The subject's forehead will be rested on his/her forearm on a table in front of him/her. A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2T blade will be cleaned with an alcohol pad. The M2T blade will be used, at an angle of 45 without causing discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 3 min. Subjects will be instructed to put an ice pack on the area if they feel any burning sensations after the session. This procedure will be repeated twice a week for four weeks.

IASTM group

Firstly, the subject will lay supine with no pillow under his/ her head then the subject will rotate his/her head and neck away from the side which will be treated. Therapist will sit or stand at the corner, edge or top of the treatment table and therapist will place one hand proximal to the shoulder with skin on skin and therapist's fingers pointing towards the subject's elbow on the same side. Other hand of the therapist will be placed inferior to the subject's jaw (body of the mandible), using it as a handle, with fingers pointing towards the top of the subject's head. Then therapist will lean into the subject to the tissue depth barrier, wait and follow each subtle release three-dimensionally. Therapist should avoid forcing the tissue or slipping or gliding over the skin. The technique should be applied for at least five minutes for optimal results. This procedure will be repeated twice a week for four weeks.

myofascial release group

Postural correction exercises will be applied for patients in groups A and B. This program will be conducted according to the protocols of exercise will be performed as 3 sets of 10 repetitions each for 2 times/ week for 4 weeks. The patients will be instructed to continue the exercises as a daily home program to influence the self-correction kinesthetic awareness. Exercises will be performed while the patients in a neutral sitting posture

IASTM groupmyofascial release group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient's age will be between 18-25 years old.
  • Subjects with mechanical neck pain localized to cervical and periscapular region.
  • Subjects with at least one trigger point in the upper trapezius and/or levator scapulae muscles
  • Subjects should report mechanical neck pain of at least 30 mm on a visual analogue scale (VAS). The scale is ranged from 0 mm (no pain) to 100 mm (worst imaginable pain).
  • Subjects who use computers daily for at least two hours and are involved in distance learning for at least three months.

You may not qualify if:

  • Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases.
  • Sensory problems at mid or upper back
  • A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication
  • History of head and upper trunk trauma or surgery.
  • Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Misr university for scientific and technology, Egypt

Cairo, 34518, Egypt

Location

Related Publications (1)

  • Shewail F, Abdelmajeed S, Farouk M, Abdelmegeed M. Instrument-assisted soft tissue mobilization versus myofascial release therapy in treatment of chronic neck pain: a randomized clinical trial. BMC Musculoskelet Disord. 2023 Jun 3;24(1):457. doi: 10.1186/s12891-023-06540-5.

MeSH Terms

Conditions

Neck PainSoft Tissue Injuries

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Fatma Hanafy

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 16, 2022

First Posted

January 28, 2022

Study Start

February 1, 2022

Primary Completion

March 15, 2022

Study Completion

March 22, 2022

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations