- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05973682
Effects of Post Isometric Relaxation With Scapular Stabilization Exercises
Effects of Post Isometric Relaxation With Scapular Stabilization Exercises on Pain, Range of Motion and Disability With Levator Scapulae Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A Randomized Controlled Trial will be conducted at Tehsil Headquarter Hospital Sharqpur Shareef, Sheikhupura through consecutive sampling technique on 30 patients with levator scapulae syndrome which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with post isometric relaxation, scapular stabilization exercises along with baseline treatment. Group B will be treated with post isometric relaxation along with baseline treatment. Baseline treatment includes hot pack, TENS, upper trapezius stretch, levator scapular stretch and pectoralis major stretch. Both groups will come thrice per week for a total of 4 weeks. Outcome measures are NPRS, universal goniometer and NDI. Data will be analysed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Keywords: Disability, Levator Scapulae, Range of Motion, Pain
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Sheikhupura, Punjab, Pakistan, 39460
- Tehsil Headquarter Hospital Sharqpur Shareef
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both Males and females
- Age range of 18-40 years
- Neck and medial border scapular pain for at least 3months
- Examination - Increased muscle tone and tenderness at neck
- Reduced Side flexion and Rotation of neck
- Positive Levator Scapular length Test
Exclusion Criteria:
- Neuropathies
- Vertebral fractures
- Pregnancy
- Previous cognitive and functional disorders
- Traumatic neck injury
- Fibromyalgia
- cancer
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: Group A: post isometric relaxation and ConVentional treatment.
Post Isometric Relaxation: The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed.
Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec.
with complete relaxation of all element, the stretch is maintained for 30 sec.
|
The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec. + hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30 second hold. static stretching exercises two sessions per week for 3 weeks were given to each patient
Conventional Physical Therapy; hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold.
static stretching exercises, two sessions per week for 3 weeks were given to each patient
|
|
Active Comparator: Group B: Conventional treatment
hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold.
static stretching exercises, two sessions per week for 3 weeks were given to each patient
|
Conventional Physical Therapy; hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold.
static stretching exercises, two sessions per week for 3 weeks were given to each patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Universal Goniometer (UG)
Time Frame: upto 4 weeks
|
Universal Goniometer (UG) used to measure ROM of cervical Spine A goniometer is an instrument that measures the available range of motion at a joint. Physical therapists commonly use a goniometer to measure the range of motion. The therapist can use a goniometer to assess the range of motion at the initial assessment. In this study range of motion of the neck will be measured. The cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides. |
upto 4 weeks
|
|
Numeric pain rate scale (NPRS)
Time Frame: upto 4 weeks
|
The numeric pain rate scale (NPRS) measures the pain at the neck region in patients with mechanical neck pain. The patient's level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst pain. NPRS is categorized into mild, moderate and severe pain. Mild pain value 1 to 3 Moderate pain value 4 to 7 Severe pain value 8 to 10 |
upto 4 weeks
|
|
Neck Disability index (NDI)
Time Frame: upto 4 weeks
|
Neck Disability index (NDI) measures the disability of the neck region in patients with mechanical pain. NDI questionnaire will be used to assess disability. It comprises 10 items; 7 related to daily living activities, 2 related to pain and 1 to concentration. Each item is scored from 0 to 5. The total score is a percentage, with higher scores related to more significant disability. 0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete |
upto 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samrood Akram, Mphil, Riphah International University,Lahore
Publications and helpful links
General Publications
- Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
- Mahmoud NF, Hassan KA, Abdelmajeed SF, Moustafa IM, Silva AG. The Relationship Between Forward Head Posture and Neck Pain: a Systematic Review and Meta-Analysis. Curr Rev Musculoskelet Med. 2019 Dec;12(4):562-577. doi: 10.1007/s12178-019-09594-y.
- Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
- Gonzalez-Rueda V, Hidalgo-Garcia C, Rodriguez-Sanz J, Bueno-Gracia E, Perez-Bellmunt A, Rodriguez-Rubio PR, Lopez-de-Celis C. Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8334. doi: 10.3390/ijerph17228334.
- Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
- Henry JP, Munakomi S. Anatomy, Head and Neck, Levator Scapulae Muscles. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553120/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- REC/RCR & AHS/23/0127 Kainat
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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