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Completed

NCT Number: NCT06460532

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sehat Medical Complex

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baseline treatment

Other

Transcutaneous Electric Nerve Stimulation (TENS) of Care Vision company 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.

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: upto 4 weeks

    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

  2. Neck disability Index (NDI)

    Time frame: upto 4 weeks

    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.

  3. Universal Goniometer

    Time frame: upto 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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