Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials (MNP)

The purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: high power pain threshold ultrasound; Other: traditional therapy

Detailed Description

Myofascial pain syndrome is a common musculoskeletal pain disorder affecting almost 95% of people with chronic pain disorders and is a common finding in especially pain management centres.It is characterized by trigger points, defined as hyperirritable spots within taut bands of skeletal muscle fibers. The syndrome is associated with tenderness in the muscle, referred pain, spasm and restriction of motion. Patients with MPS begin with one active MTrP (called the primary MTrP) in the affected muscles due to chronic repetitive minor muscle strain, poor posture, systemic diseases, or neuro-musculoskeletal lesions. When not treated correctly, expansion of the pain region and additional active MTrPs (called secondary or satellite MTrPs) will develop one of the most appropriate treatments for trigger points ultrasound therapy. The high-power pain threshold ultrasound (HPPTUS) technique is one of the ultrasound modifications used to treat trigger points In 2004, Majlesi et al. performed the first clinical study to compare this technique with the traditional ultrasound technique in patients with myofascial trigger points. The results showed that HPPTUS was much more effective than the traditional technique, and pain reduction and improved range of motion (ROM) were significant in a smaller number of sessions.sixty patients with mechanical neck pain will be assigned randomly to two equal group. one group will receive high power pain threshold ultrasound and traditional therapy and the other receive traditional therapy alone for four weeks.

.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12511
    • Al Shaymaa Shaaban Abd El Azeim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with mechanical neck pain from both genders.
• age between 19 and 38 years
• patients will be required to have active TrPs in the upper trapezius and levator muscle and neck pain

Exclusion Criteria:

• Patients will be excluded if they have History of whiplash injury,
• History of cervical spine surgery,
• Cervical radiculopathy or myelopathy,
• Having undergone physical therapy within the past 3 months before the study
• Non- rheumatologic diseases as multiple sclerosis,
• thyroid dysfunction and chronic infection and Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high power pain threshold ultrasound; the patients will receive high power pain threshold ultrasound and traditional therapy twice a week for four weeks	Other: high power pain threshold ultrasound; After explaining the procedure, and the trigger points will be marked by a physical therapist that . Then, the hand placed next to the prone position with the head in the neutral position, and the hands placed next to the body. The frequency was set to 1 MHz, and the intensity increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe will be held there for 4 s; then, the intensity was reduced by 50%, and the probe was moved over and around the trigger point. This process is done several times for three minutes.; Other: traditional therapy; the patients will receive traditional therapy in the form of postural correction exercise, active range of motion and stretching exercise for cervical muscles
Active Comparator: traditional therapy; the patients will receive traditional therapy twice a week for four weeks	Other: traditional therapy; the patients will receive traditional therapy in the form of postural correction exercise, active range of motion and stretching exercise for cervical muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	pain will be measured by visual analogue scale	up to four weeks
pressure pain threshold	commander algometer device will be used to measure pressure pain threshold	up to four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neck disability	neck disability index will be used to measure neck disability.	up to four weeks
muscle amplitude and fatigue	electromyography will be used to measure muscle amplitude and fatigue	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: high power pain threshold ultrasound; mechanical neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: p.t.REC/012/003619

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No