NCT05860049

Brief Summary

Purpose of the study was to investigate the effect of adding instrument assisted soft tissue mobilization to core stability training in treatment of chronic mechanical neck pain on pain level, cervical ROM, proprioception, muscle activity, H-reflex, and functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

April 28, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 29, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

April 28, 2023

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Pain level

    The pain level was measured by visual analogue scale.The VAS is a 100-mm horizontal line anchored by word descriptors at each end by ''no pain'' on the left and ''worst imaginable pain'' on the right. The minimum score means it is better.

    4 weeks

  • Cervical range of motion and proprioception

    Cervical range of motion and proprioception were measured using CROM.

    4 weeks

  • Functions

    Functions were measured by Arabic version of Neck Disability Index. It is consisting of 10 items with six choices (0-5), Each item is scored from zero (no disability) to five (total disability). Minimum score means it is better.

    4 weeks

  • Muscle activity

    Muscle activity was measured by electromyography (EMG).

    4 weeks

  • H-reflex

    H-reflex was measured by EMG.

    4 weeks

Study Arms (2)

Conventional physiotherapy + Core stability

ACTIVE COMPARATOR

They received conventional physical therapy and core stability for 4 weeks.

Other: Conventional physiotherapyOther: Core stability

Conventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM)

EXPERIMENTAL

They received conventional physical therapy, core stability, and IASTM technique for 4 weeks.

Other: Conventional physiotherapyOther: Core stabilityDevice: Instrument assisted soft tissue mobilization

Interventions

All participants in both groups (A and B) received conventional physiotherapy program including infrared thermotherapy, transcutaneous electrical nerve stimulation, stretching exercises for for Upper Trapezius, Levator Scapulae, Sternocleidomastoid and Scalenes muscles, and active neck ROM exercises, 3 sessions per week, for 4 weeks.

Conventional physiotherapy + Core stabilityConventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM)

All participants in both groups (A and B) received core stability exercises in the form of bridging exercise, bridging exercise on a ball, plank, and side plank 3 sessions per week, for 4 weeks.

Conventional physiotherapy + Core stabilityConventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM)

Each participant in group (B) was seated in a comfortable position. The participant's forehead rested on his/her forearm on a table in front of him/her. A lubricant (Vaseline) was applied to the skin around the neck area prior to treatment, and the M2T blade (Figure 4) was cleaned with an alcohol pad. First, the M2T blade was used to find the exact areas of restriction in the RT upper trapezius. Then, the M2T blade was used at an angle of 45°, utilizing treatment planes 1, 2, and 3, to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion for approximately 3 minutes. This procedure was repeated twice a week, for 4 weeks.

Conventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed as having chronic mechanical neck pain.
  • Patient's age between 18-55 years old.

You may not qualify if:

  • Subjects with any specific neck pathology as radiculopathy, rheumatoid arthritis and systemic diseases.
  • sensory problems at mid or upper back.
  • A history of head and upper trunk trauma or surgery.
  • severe disorders of the cervical spine such as disk prolapse and cervical stenosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ismailia Medical Complex

Ismailia, 0643213902, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Core Stability

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Haytham El-Hafez, PhD

    Professor, Cairo university

    STUDY CHAIR

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
physical therapist

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 16, 2023

Study Start

August 29, 2023

Primary Completion

January 29, 2024

Study Completion

March 30, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations