Subthreshold Stimulation on Chronic Low Neck Pain Myofascial Trigger Points

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Subthreshold Electrical stimulation

About this trial

This is an interventional treatment trial for Chronic Neck Pain

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: chronic neck pain One or more trigger point Exclusion Criteria: any musculoskeletal or neuromuscular diseases

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1

Group II

Arm Description

This group will receive subthreshold stimulation

This group will receive no stimulation

Outcomes

Primary Outcome Measures

Electromyographical signals

We will record the the Trapezius muscle activity of both sides.

Pressure sensitivity using pressure ergometer

We will measure pain threshold produced from Trapezius muscle

Secondary Outcome Measures

Neck pain and disability

We will record the level of pain and disability in neck using neck pain and disability index. standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score

Functional ability

We will measure the functional ability. The Copenhagen Neck Functional Disability Scale has been developed for those who have neck pain and disabilities due to the pain. The scale includes questions relating to headache, ability to sleep and to concentrate and activities of daily living.

Full Information

NCT ID

NCT06054672

First Posted

September 8, 2023

Last Updated

September 19, 2023

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT06054672

Brief Title

Subthreshold Stimulation on Chronic Low Neck Pain Myofascial Trigger Points

Official Title

Effect of Subthreshold Stimulation on Pain and Muscle Activity in Patients With Chronic Low Neck Pain and Myofascial Trigger Points

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 30, 2023 (Anticipated)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.

Detailed Description

The study will include 2 groups. One group will receive subthreshold stimulation and other will not receive any treatment. The measurements will include pain and myscle activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Neck Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

This group will receive subthreshold stimulation

Arm Title

Group II

Arm Type

No Intervention

Arm Description

This group will receive no stimulation

Intervention Type

Device

Intervention Name(s)

Subthreshold Electrical stimulation

Intervention Description

We will use a electrotherapy device to deliver subthreshold Electrical stimulation

Primary Outcome Measure Information:

Title

Electromyographical signals

Description

We will record the the Trapezius muscle activity of both sides.

Time Frame

2 months

Title

Pressure sensitivity using pressure ergometer

Description

We will measure pain threshold produced from Trapezius muscle

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Neck pain and disability

Description

We will record the level of pain and disability in neck using neck pain and disability index. standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score

Time Frame

2 months

Title

Functional ability

Description

We will measure the functional ability. The Copenhagen Neck Functional Disability Scale has been developed for those who have neck pain and disabilities due to the pain. The scale includes questions relating to headache, ability to sleep and to concentrate and activities of daily living.

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: chronic neck pain One or more trigger point Exclusion Criteria: any musculoskeletal or neuromuscular diseases

Chronic Neck Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial