- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07776327
Analyzing Positional Release Therapy and Dry Needling
Analyzing Positional Release Therapy and Dry Needling to Improve Pain and Function in Levator Scapulae Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Following the screening, participants will be randomized to receive the experimental or the controlled treatment in a1:1 ratio. Computer-generated random numbers will be used for Randomization. After obtaining the basic information, a unique code will be provided to each included patient. The outcome assessor will be blinded to the type of treatment. Patients and investigator could not be blinded due to the nature of treatment. Group "A "(experimental group) will receive Positional Release Technique on Levator Scapulae (Both if Necessary) Group "B" (control group) will receive (control group) will receive Dry needling treatment ,along with Neck strengthening exercises.
All patients will be Assessed for Pain , ROM and Functional Activities at base line and after 4 weeks.
Visual Analogue Scale(VAS) and CROM will be used for pain and ROM respectively.Neck Disability Index (NDI), Oxford Scale, ) will be used for Muscle strength and Daily life disaility Global Rating for patient's assessment of their own progress or decline during a particular course of treatment. and finaly EuroQol-5D (EQ-5D) to evaluate health-related quality of life. Mobility, self-care, routine activities, pain/discomfort, and anxiety/depression are the five main variables that are assessed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iram Iqbal Shamsi, MPhil
- Phone Number: +92 3012135230
- Email: iramiqbalshamsi@gmail.com
Study Locations
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Sindh
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Karachi, Sindh, Pakistan, 74200
- Recruiting
- Sind Institute of Physical Medicine & Rehabilitation
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Contact:
- Iram Iqbal Shamsi, Mphil.
- Phone Number: 03012135230
- Email: iramiqbalshamsi@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
18-40 years Willing to participate Having Positive Levator scapulae Test -
Exclusion Criteria:
Any history related to spinal surgery, Previous administration of epidural injections. Neck pain due to specific pathology, Neurological deficits (Myelopathy) and Clinical disorder contraindicated to exercise
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positional Release Technique PRT
Group "A"(experimental group) will receive Positional Release Technique on Levator scapulae (may be both if necessary).along with Neck strengthening exercises. Patient will be in supine lying with the elbows to the side of the upper body therapist sitting behind stabilizing superior border of scapula, with other hand holding the occiput region. Palpating tender points around superior-medial border of scapula and with occipital hand move the head and neck towards painful side. Pressure will be applied to a Pain perception of 10 and than Physiotherapis MOve the Neck in Different combilation of Movemnt Like Flexion , Side bending Rotation or Extension untill Patient start to feel a minimum releif of Tender point of 75 %. three sets on each side with 30 seconds hold on tender point. A rest of 15 seconds will be given between all sets. Following exercises will be given Rowing, horizontal abduction, shrug, horizontal abduction with ER, prone shoulder extension |
This Techniques Introduce in 1980 by DO Jones.
By name of Spontaneous Release than Strain Counterstrain but Now Term PRT is Used Gobally.
Muscle rlaxation is Achieved by Putting the muscle in Mos comfortable postion
Despite using the same type of filiform (solid) needles, it is not the same as acupuncture.
While acupuncture regulates the body's energy flow through conventional channels, dry needling is a Western medical treatment used specifically to relieve pain and release tight muscle knots.
|
|
Active Comparator: Active Comparator: Dry Needling Therapy
Group "B" (control group) will receive Dry needling treatment consisting along with Neck strengthening exercises. Patient will be in prone lying with the elbows adducted the upper body weight rests on the elbows, for further enhancement patient flexes the neck and lets the shoulder girdle relax. A pillow will be placed under shoulder to protrude scapula, exposing the super medial border for palpation and Introducing needles from a superior to inferio posterior angle to avoid lung lobe. With therapist wearing glove Alcohol swaps will be used to clean the area to be treated, A 30-40mm (0.32-0.35 gauge) needle will be used depending on body size. Following exercises will be given Rowing, horizontal abduction, shrug, horizontal abduction with ER, prone shoulder extension |
This Techniques Introduce in 1980 by DO Jones.
By name of Spontaneous Release than Strain Counterstrain but Now Term PRT is Used Gobally.
Muscle rlaxation is Achieved by Putting the muscle in Mos comfortable postion
Despite using the same type of filiform (solid) needles, it is not the same as acupuncture.
While acupuncture regulates the body's energy flow through conventional channels, dry needling is a Western medical treatment used specifically to relieve pain and release tight muscle knots.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS Visual Analogue Scale VAS Visual Analogue Scale
Time Frame: Baseline and After Four weeks of Treatment
|
The visual analogue scale is used for measurement of pain intensity.
It is a continuous scale.
It comprises a horizontal/vertical 10 centimeters or 100 millimeters line.
The higher scores shows higher pain intensity and lower scores shows lower pain intensity.Left Anchor (0 cm): Represents "No pain" and The Right Anchor (100 cm): Represents "Worst possible pain".
Increase in cm indicate worsening of the pain.
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Baseline and After Four weeks of Treatment
|
|
The Oxford Muscle Scale
Time Frame: Baseline and After Four weeks of Treatment
|
The Oxford muscular Scale, sometimes called the Medical Research Council or MRC scale, as a standardized instrument to measure muscular strength and power, Evaluate and grade manual muscle strength and power on a standardized scale from 0 to 5.
Where 0 Means No contraction (lowest) and grade 5 (highest) muscle exhibits normal strength and can move through a full range of motion against maximal, firm resistance.
Increase in Grades represent Improving in Strength and recovery while decrease in grade shows weakness and decline in strength.
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Baseline and After Four weeks of Treatment
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Cervical Range of Motion (CROM) Universal Goniometery
Time Frame: Baseline and After Four weeks of Treatment
|
The cervical spine's (neck's) functional mobility is determined using the Cervical Range of Motion (CROM) test.
It determines how far a person can move their head in various directions, to assist diagnose neck discomfort, evaluate the healing process following an accident, and monitor the course of rehabilitation.Cervical goniometry is the clinical method of measuring neck mobility using a standard handheld universal goniometer.
The goniometer's stationary arm always tracks a fixed reference line relative to the ground or torso.
The moving arm follows the structural movement of the skull.
Measures CROM in degrees.
Increase in degrees denote improvement and increase ROM
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Baseline and After Four weeks of Treatment
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EuroQol-5D (EQ-5D)
Time Frame: Baseline and After Four weeks of Treatment
|
Measure generic health-related quality of life (HRQoL).
It is one of the most widely used Patient-Reported Outcome Measures (PROMs) globally.
The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
|
Baseline and After Four weeks of Treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index (NDI)
Time Frame: Baseline and After Four weeks of Treatment
|
The gold-standard Client reported questionnaire to measure how much neck discomfort interferes with day-to-day functioning is the Neck Disability Index (NDI).Measure how much neck pain affects a patient's daily activities and to track their progress over time.
It consists of 10 sections covering areas like pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation.
Each section is scored from 0 (no disability) to 5 (severe disability), giving a total possible raw score of 50.
Scores of 0-4 means No disability, Neck pain has negligible impact on daily living where scores of 25 - 34 reflects complete disability, Patient is bedbound or severely incapacitated by pain.
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Baseline and After Four weeks of Treatment
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Global Rating of Change (GRC)
Time Frame: Baseline and After Four weeks of Treatment
|
A simple, self-filled questionnaire used to gauge a patient's perceived progress or decline over time.
It enables patients to list the extent to which their condition has improved since beginning an intervention.
A single-item outcome measure used in clinical practice and research to quantify a patient's self-perceived improvement or deterioration over a specific period.
The most heavily validated and widely used version is the 15-point scale (ranging from -7 to +7.
Positive Scores (+1 to +7): Indicate improvement, where +1 represents "a tiny bit better" and +7 represents "a very great deal better", Neutral Score (0): Indicates the condition is unchanged or exactly "the same".
Negative Scores (-1 to -7): Indicate worsening, where -1 represents "a tiny bit worse" and -7 represents "a very great deal worse".
Scores of +4 or +5 and above indicate a definitive, highly successful clinical outcome.
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Baseline and After Four weeks of Treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIShamsi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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