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)
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high power pain threshold ultrasound
traditional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring high power pain threshold ultrasound, mechanical neck pain
Eligibility Criteria
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.
Sites / Locations
- Al Shaymaa Shaaban Abd El Azeim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high power pain threshold ultrasound
traditional therapy
Arm Description
the patients will receive high power pain threshold ultrasound and traditional therapy twice a week for four weeks
the patients will receive traditional therapy twice a week for four weeks
Outcomes
Primary Outcome Measures
pain intensity
pain will be measured by visual analogue scale
pressure pain threshold
commander algometer device will be used to measure pressure pain threshold
Secondary Outcome Measures
neck disability
neck disability index will be used to measure neck disability.
muscle amplitude and fatigue
electromyography will be used to measure muscle amplitude and fatigue
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05540093
Brief Title
Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials
Acronym
MNP
Official Title
Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
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
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.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
high power pain threshold ultrasound, mechanical neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
high power pain threshold ultrasound and traditional therapy
Masking
Outcomes Assessor
Masking Description
permuted block randomization
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high power pain threshold ultrasound
Arm Type
Experimental
Arm Description
the patients will receive high power pain threshold ultrasound and traditional therapy twice a week for four weeks
Arm Title
traditional therapy
Arm Type
Active Comparator
Arm Description
the patients will receive traditional therapy twice a week for four weeks
Intervention Type
Other
Intervention Name(s)
high power pain threshold ultrasound
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional therapy
Intervention Description
the patients will receive traditional therapy in the form of postural correction exercise, active range of motion and stretching exercise for cervical muscles
Primary Outcome Measure Information:
Title
pain intensity
Description
pain will be measured by visual analogue scale
Time Frame
up to four weeks
Title
pressure pain threshold
Description
commander algometer device will be used to measure pressure pain threshold
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
neck disability
Description
neck disability index will be used to measure neck disability.
Time Frame
up to four weeks
Title
muscle amplitude and fatigue
Description
electromyography will be used to measure muscle amplitude and fatigue
Time Frame
up to four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Al Shaymaa Shaaban Abd El Azeim
City
Giza
ZIP/Postal Code
12511
Country
Egypt
12. IPD Sharing Statement
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Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials
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