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Adding Instrument Assisted Soft Tissue Mobilization to Core Stability Training in Chronic Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
istrument assisted soft tissue mobilization
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed as having chronic mechanical neck pain. Patient's age between 18-55 years old. Exclusion Criteria: Subjects with any specific neck pathology as radiculopathy, rheumatoid arthritis and systemic diseases. sensory problems at mid or upper back. A history of head and upper trunk trauma or surgery. severe disorders of the cervical spine such as disk prolapse and cervical stenosis.

Sites / Locations

  • Ismailia Medical ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conventional physiotherapy

conventional physiotherapy,core stability training and istrument assisted soft tissue mobilization

Arm Description

They will receive conventional physical therapy (Superficial thermotherapy will be applied by an infrared lamp (250 watts), located 50cm from the patient's neck for 15 minutes. Electrotherapy will be provided in the form of TENS with a frequency of 100Hz and 250 microsecond pulses for 45 minutes using two 4x6cm electrodes placed bilaterally at the spinous process of C7 vertebra. Stretching exercises for Upper Trapezius, Levator Scapulae, Sternocleidomastoid and Scalenes muscles, each stretching exercise maintain 30 second and repeated 5 times for each side. Active range of motion exercises for neck extension, neck flexion, neck rotation, and neck lateral flexion to both directions, that includes active movement without resistance as follow: Patient sitting on the chair, therapist standing behind the patient, asking the patient to move his neck smoothly in extension, flexion, rotation, and lateral flexion to both directions for 1set 5 repetitions.

They will receive conventional physical therapy core stability exercise and IASTM technique.

Outcomes

Primary Outcome Measures

pain level
pain level will be measured by visual analogue scale.The VAS is a 100-mm horizontal line anchored by word descriptors at each end by ''no pain'' on the left and ''worst imaginable pain'' on the right. The minimum score means it is better.
Cervical range of motion and proprioception
Cervical range of motion and proprioception will be measured using CROM.
Functions
Functions will be measured by Arabic version of Neck Disability Index.It is consisting of 10 items with six choices (0-5), Each item is scored from zero (no disability) to five (total disability). Minimum score means it is better
Muscle activity
Muscle activity measured by EMG.
H-reflex
H-reflex will be measured by EMG

Secondary Outcome Measures

Full Information

First Posted
April 28, 2023
Last Updated
September 9, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05860049
Brief Title
Adding Instrument Assisted Soft Tissue Mobilization to Core Stability Training in Chronic Mechanical Neck Pain
Official Title
Adding Instrument Assisted Soft Tissue Mobilization to Core Stability Training in Chronic Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

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
Purpose of the study is to investigate effect of adding instrument assisted soft tissue mobilization to core stability training in treatment of chronic mechanical neck pain on pain level, cervical ROM, proprioception , Muscle activity ,H-reflex and Functions
Detailed Description
Neck pain (NP) is a common musculoskeletal condition with a lifetime incidence rate between 22% and 70%. Neck pain is commonly a recurrent condition with remissions and exacerbation that do not completely resolve. A history of previous injury to the neck (including whiplash, sports and work injuries etc.) increases the likelihood of chronic pain. As one ages, more chronic neck pain persists. Mechanical neck pain is pain and/or stiffness in the neck or shoulder girdle region which was reproducible with neck movements. Mechanical neck pain is the most common type found in neck-pain disorders. Studies have demonstrated altered behavior of the cervical muscles in mechanical neck-pain patients. Mechanical neck pain produces mobility restriction, functional disability, decrease in muscle strength and decrease in health related quality of life. Several treatment techniques and methods are used to rehabilitate pathologies of the cervical spine, including manual therapy, massage, stretching, soft-tissue techniques, and therapeutic exercise. Manual therapy includes hands-on therapy techniques, such as soft tissue mobilization and massage techniques, as well as techniques using therapeutic equipment, such as stainless steel tools, that allow clinical therapists to identify and treat soft tissue dysfunctions. Instrument-assisted soft tissue mobilization (IASTM) encompasses a broad range of techniques to treat soft tissue deficiencies. Tools used for IASTM produce micro-trauma to soft tissue for healing and restoring normal elasticity and function. In recent years, Core stability training has become a popular fitness trend that has begun to be applied in rehabilitation programs and in sports medicine. Core exercises have a positive effect on reducing lower back pain, improving upper extremities in breast cancer patients and lower extremities in patients with total hip and knee arthroplasty, as well as performance improvement for athletes. Core exercises are taken seriously in rehabilitation, medical care, and sports. The core stability exercise program can be described as enhancing the ability to ensure a stable neutral spine position. Statement of the problem This study will answer the following question: Is there is effect of adding instrument assisted soft tissue mobilization to core stability in treatment of mechanical neck pain? Purpose of the study: Purpose of the study is to investigate effect of adding instrument assisted soft tissue mobilization to core stability in treatment of mechanical neck pain on pain level, cervical ROM, proprioception , Muscle activity ,H-reflex and Functions. Significance of the study: Study of Mohamed et al., (2020) investigated and compared the effects of instrument assisted soft tissue mobilization (IASTM) using m2t blade and trigger point release (TPR) in terms of neck lateral flexion and rotation range of motion on upper trapezius (UT) myofascial trigger points (MTrPs) in mechanical neck pain. Both groups showed significant effects in improving range of motion. There was no significant difference in neck lateral flexion and rotation between the two groups. The improvements in patients who received IASTM by M2t blade could be explained through loosening and removal of scar tissues and adhesions secondary to skin scraping which decreased soft tissue consistency and improved range of motion. It also induced vasodilation response and microvascular hemorrhage; so provided oxygen, nutrients and removed metabolic end products and inflammatory mediators which improved pain level and ppt. Konstantinos et al., (2012) found that IASTM techniques combined with neuromuscular retraining exercises can significantly reduce pain and improve the corresponding function of patients with cervical pain compared to the application of the same exercises and a simple massage. Rajalaxmi et al., (2020) analyzed the efficacy of multistep core stability exercise with and without conventional neck exercises in the treatment of chronic non-specific neck pain a Randomized Controlled Trial. GROUP A received neck stability exercise and GROUP B received neck stability and core stability exercises. Both the groups received exercises for 45 min session per day for 6 days a week for 12 weeks. Pre and post-test measured using VAS, NDI, CCFT. Both the group received a hot pack for 10min as a common intervention. On comparing the mean value of Group A & Group B on VAS and NDI Group B (neck stability with core stability exercise) showed 3.5 and 33.4 post-test values which were more effective than Group A (neck stability exercise) 5. 3 and 45.2 at P≤ 0.001. On the Craniocervical flexion Group B had shown 29.5 greater mean value when compared to Group A 24.7 at P≥ 0.001. Higher proportions of patients improved in group B compared to group A. Core stability exercise group demonstrated and benefited significant improvements in NDI, VAS, and CCFT scores. Mohsen et al., (2019) showed that 12 sessions of neck, core, and combined stabilization training in the neck region could improve the tolerance and pain of the elderly with non-specific chronic neck pain. This is the first study to investigate the effect of adding IASTM to core stability exercise in treatment of mechanical neck pain. Delimitation This study will be delimited to: Subjects will be divided randomly into two groups. Age of the subjects ranged from 18 and 55 with mechanical neck pain. (Mohamed et al., 2020) Subjects will be selected from outpatient clinic of Ismailia Medical Complex. Pain level will be measured by VAS. Cervical range of motion and proprioception will be measured using CROM. Functions will be measured by Arabic version of Neck Disability Index. Muscle activity and H-reflex will be measured by EMG. Basic Assumption It will be assumed that: All subjects will exert their best effort to be relaxed during testing procedures. All subjects will follow the researcher's instructions and advices. Psychological condition will be the same for all subjects. Hypotheses: There will be no statistically significant effect of adding IASTM to core stability on pain level. There will be no statistically significant effect of adding IASTM to core stability on cervical ROM. There will be no statistically significant effect of adding IASTM to core stability on proprioception. There will be no statistically significant effect of adding IASTM to core stability on muscle activity. There will be no statistically significant effect of adding IASTM to core stability on H-reflex. There will be no statistically significant effect of adding IASTM to core stability on functions.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional physiotherapy
Arm Type
Experimental
Arm Description
They will receive conventional physical therapy (Superficial thermotherapy will be applied by an infrared lamp (250 watts), located 50cm from the patient's neck for 15 minutes. Electrotherapy will be provided in the form of TENS with a frequency of 100Hz and 250 microsecond pulses for 45 minutes using two 4x6cm electrodes placed bilaterally at the spinous process of C7 vertebra. Stretching exercises for Upper Trapezius, Levator Scapulae, Sternocleidomastoid and Scalenes muscles, each stretching exercise maintain 30 second and repeated 5 times for each side. Active range of motion exercises for neck extension, neck flexion, neck rotation, and neck lateral flexion to both directions, that includes active movement without resistance as follow: Patient sitting on the chair, therapist standing behind the patient, asking the patient to move his neck smoothly in extension, flexion, rotation, and lateral flexion to both directions for 1set 5 repetitions.
Arm Title
conventional physiotherapy,core stability training and istrument assisted soft tissue mobilization
Arm Type
Experimental
Arm Description
They will receive conventional physical therapy core stability exercise and IASTM technique.
Intervention Type
Device
Intervention Name(s)
istrument assisted soft tissue mobilization
Other Intervention Name(s)
core stability exercises
Intervention Description
Each subject in group (A) will receive 12 sessions of physical therapy 3 sessions per week for 4 weeks). Each subject in group (B) will receive 8 sessions of physical therapy(two sessions per week for four weeks).
Primary Outcome Measure Information:
Title
pain level
Description
pain level will be measured by visual analogue scale.The VAS is a 100-mm horizontal line anchored by word descriptors at each end by ''no pain'' on the left and ''worst imaginable pain'' on the right. The minimum score means it is better.
Time Frame
four weeks following end of treatment
Title
Cervical range of motion and proprioception
Description
Cervical range of motion and proprioception will be measured using CROM.
Time Frame
four weeks following end of treatment
Title
Functions
Description
Functions will be measured by Arabic version of Neck Disability Index.It is consisting of 10 items with six choices (0-5), Each item is scored from zero (no disability) to five (total disability). Minimum score means it is better
Time Frame
four weeks following end of treatment
Title
Muscle activity
Description
Muscle activity measured by EMG.
Time Frame
four weeks following end of treatment
Title
H-reflex
Description
H-reflex will be measured by EMG
Time Frame
four weeks following end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed as having chronic mechanical neck pain. Patient's age between 18-55 years old. Exclusion Criteria: Subjects with any specific neck pathology as radiculopathy, rheumatoid arthritis and systemic diseases. sensory problems at mid or upper back. A history of head and upper trunk trauma or surgery. severe disorders of the cervical spine such as disk prolapse and cervical stenosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raghda Mahmoud, Master
Phone
01007243178
Email
r_s_adam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raghda Mahmoud, Master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ismailia Medical Complex
City
Ismailia
ZIP/Postal Code
0643213902
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmad, doctor
Phone
0643213901

12. IPD Sharing Statement

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Adding Instrument Assisted Soft Tissue Mobilization to Core Stability Training in Chronic Mechanical Neck Pain

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