NCT04702100

Brief Summary

the aim of this study is to investigate the efficacy of instrumented assisted soft tissue mobilization versus integrated neuromuscular inhibition technique on mechanical non-specific neck pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

Study Start

First participant enrolled

January 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

January 6, 2021

Last Update Submit

June 22, 2022

Conditions

Keywords

instrument-assisted soft tissue mobilizationintegrated neuromuscular inhibition technique

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain

    up to four weeks

Secondary Outcomes (3)

  • neck disability

    up to four weeks

  • muscle amplitude in the form of normalized root mean square (RMS)

    up to four weeks

  • muscle fatigue in the form of median frequency

    up to four weeks

Study Arms (3)

instrument assisted soft tissue mobilization

EXPERIMENTAL

the patients will receive instrument-assisted soft tissue mobilization+conventional therapy three times per week for four week

Other: instrument assisted soft tissue mobilizationOther: conventional therapy

integrated neuromuscular inhibition technique

EXPERIMENTAL

the patients will receive integrated neuromuscular inhibition technique+ conventional therapy. three times a week for four week

Other: integrated neuromuscular inhibition techniqueOther: conventional therapy

conventional therapy

ACTIVE COMPARATOR

the patients will receive conventional therapy three times a week for four week

Other: conventional therapy

Interventions

the patients will receive instrument-assisted soft tissue mobilization:The subject was seated in a relaxed sitting position. M2T blade was used to find specific areas of restriction on RT upper trapezius. Then treatment plane 1 - 2 and 3 were used.The lubricant (Vaseline) was applied to the skin around the neck area prior to treatment and the tool was cleaned with an alcohol preparation pad. Then by using M2T blade with angle 45, we were giving long slow strokes without causing any discomfort or pain over muscle starting from its insertion up to its origin approximately for 2 to 3 min repeated two times.

instrument assisted soft tissue mobilization

will receive integrated neuromuscular inhibition technique: from supine lying position.we the patients will perform ischemic compression at trigger points then positional release technique and finally muscle energy technique.

integrated neuromuscular inhibition technique

the patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches

conventional therapyinstrument assisted soft tissue mobilizationintegrated neuromuscular inhibition technique

Eligibility Criteria

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

You may qualify if:

  • diagnosed as non-specific neck pain with upper trapezius active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
  • body mass index from 18 to 25 kg/m2
  • their ages from 18-35

You may not qualify if:

  • if they had trigger point injections within the past 6 months
  • history of neck or upper back surgery, trauma or fracture
  • history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
  • cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Shaymaa Shaaban Abd El Azeim

Giza, 12511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
random generator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: instrument assisted soft tissue mobilization and integrated neuromuscular inhibition technique
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 8, 2021

Study Start

January 1, 2021

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

June 23, 2022

Record last verified: 2022-06

Locations