Effects of Diaphragm Manual Therapy Verses Sustained Natural Apophyseal Glide in Mechanical Neck Pain

Neck Pain Clinical Trial

Official title:

Effects of Diaphragm Manual Therapy Versus Sustained Natural Apophyseal Glide on Pain, Range of Motion and Functional Disability in Patients With Mechanical Neck Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460532
• Other study ID #: REC/RCR & AHS/23/0196 Anam
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Samrood Akram, MPhil
• Phone: 923324806143
• Email: samrood.akram[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Study aimed to compare diaphragm manual therapy and Sustained Natural Apophyseal Glide on pain, range of motion and functional disability in patients with mechanical neck pain.

Description:

This project will be a Randomized Clinical Trial conducted to check the effects of Diaphragm manual therapy versus sustained natural apophyseal glide on pain, range of motion and functional disability in patients with mechanical neck pain at Sehat Medical Complex Lahore through non-probability convenient sampling technique on 34 patients will be allocated using simple random sampling through Computer generated Randomization into Group A and Group B. Group A will be treated with Diaphragm Manual Therapy and baseline treatment was given and Group B with Sustained Natural Apophyseal Glide and baseline treatment was given. All Exercise were performed 3 times a week for total 4 weeks. Outcome measures will be conducted through NPRS for pain, ROM measured by Goniometer, and Neck Disability Index (NDI) for Disability after 4 weeks. Data was analyzed during SPSS software version 25. After assessing the normality of data by the Shapiro-Wilk test, it decided whether either parametric or non-parametric tests were used within a group or between two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age group between 18 and 40 years

• Both gender male and female

• Individuals having localized pain or stiffness in the cervical spine or both combined between C3 and C7 without upper-limb radiculopathy

• Pain reported on NPRS score ?3 to <7/10 in neck region for more than 3 months.

• Limited Neck ROM

• Negative Spurling's test, traction test, upper limb tension test, and shoulder abduction test

Exclusion Criteria:

Patients were excluded if they were diagnosed with the following conditions for ?6 months

• Tuberculosis, carcinoma, heart disease, and osteoporosis

• Neural disorders due to prolapsed intervertebral disc

• Any trauma or localized infection in neck region

• Upper motor neuron disease, cervical stenosis, and metabolic diseases in bone and joint

• Hyper flexibility

• Open sores

• Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants

• Psychiatric diseases such as phobia/obsession and depression

• Allergy to hot pack

• Patients with history of surgery in cervical spine region with in a year.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Baseline treatment
Transcutaneous Electric Nerve Stimulation (TENS) will be applied, with a pulse duration of 250 microseconds at a frequency of 80 Hz for 15 min in the suboccipital region and the trapezius bilaterally. The exercise protocol was taught to patients in the first session and performed once a day for 21 sessions during the 3 weeks of treatment. The physiotherapist reinforced it in each of the three individual sessions.

Locations

Country	Name	City	State
Pakistan	Sehat Medical Complex	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w. — View Citation

Haghighat F, Moradi R, Rezaie M, Yarahmadi N, Ghaffarnejad F. Added Value of Diaphragm Myofascial Release on Forward Head Posture and Chest Expansion in Patients With Neck Pain: A Randomized Controlled Trial. 2020.

Jabbar KM, Gandomi F. The comparison of two corrective exercise approaches for hyperkyphosis and forward head posture: A quasi-experimental study. J Back Musculoskelet Rehabil. 2021;34(4):677-687. doi: 10.3233/BMR-200160. — View Citation

Pal A, Misra A. EFFECTIVENESS OF SNAG MOBILIZATION ON COMPUTER PROFES-SIONALS WITH MECHANICAL NECK PAIN AND MOBILITY DEFICIT. Int J Physiother Res. 2019;7(2):3022-27.

Saleem I, Zahoor IA, Rana AA, Sarfraz S, Ibrahim M, Ghaffar N. Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects on Pain, Range of Motion and Neck Disability in Patients with Chronic Neck Pain: Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects. Pakistan Journal of Health Sciences. 2022:154-8.

Simoni G, Bozzolan M, Bonnini S, Grassi A, Zucchini A, Mazzanti C, Oliva D, Caterino F, Gallo A, Da Roit M. Effectiveness of standard cervical physiotherapy plus diaphragm manual therapy on pain in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:481-491. doi: 10.1016/j.jbmt.2020.12.032. Epub 2021 Feb 16. — View Citation

Tatsios PI, Grammatopoulou E, Dimitriadis Z, Koumantakis GA. The Effectiveness of Manual Therapy in the Cervical Spine and Diaphragm, in Combination with Breathing Reeducation Exercises, in Patients with Non-Specific Chronic Neck Pain: Protocol for Development of Outcome Measures and a Randomized Controlled Trial. Diagnostics (Basel). 2022 Nov 4;12(11):2690. doi: 10.3390/diagnostics12112690. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	The primary outcome was pain assessment by the Numeric Pain Rating Scale (NPRS). This is a reliable self-reported 11-point numeric scale, where each number reflects the intensity of the pain referred by the patient: "0" stands for "no pain" and "10" for "the worst possible pain". Patients verbally selected 3 values that were most in line with the intensity of pain that they had experienced in the previous 24 h, corresponding to current pain and to his/her best and worst pain. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 h. NPRS was assessed before and after each treatment session. The reliability is (r = 0.96 and 0.95, respectively) and validity correlations range from 0.86 to 0.95	upto 4 weeks
Primary	Neck disability Index (NDI)	Disability was assessed using the Urdu version of the Neck Disability Index (NDI). This is a reliable scale and was self-assessed by the patients and filled in at the beginning and at the end of the whole treatment. The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage. The reliability is between 0.50 and 0.98.	upto 4 weeks
Primary	Universal Goniometer	An instrument called a goniometer was used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer. The reliability is (r = .58). Neck ROM will be measured in this study using a Universal Goniometer.	upto 4 weeks