Low Back PainNCT05840666
Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method in Patients With Non-Specific Chronic Low Back Pain
A study testing Mulligan Sustained Natural Apophyseal Glide (SNAG), McKenzie Method and Conventional Physical Therapy in people with Low Back Pain, run by Ayesha Jamil at 1 site in Pakistan.
Trial summary
Low back pain (LBP) is the most frequent complaint encountered in clinical practice. Exercises and manual therapy prescription are common physical therapy treatments prescribed for the patients presenting with chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Mulligan Sustained Natural Apophyseal Glide (SNAG), McKenzie Method and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of Both genders
- Adult patents between the 20 to 45 years of age with chronic non-specific low back pain.
- Pain intensity of at least 3 or greater on 0-10 Numeric Rating Scale.
- Modified Low Back Pain Disability Questionnaire score equal to or greater than 20%.
Who cannot join
- Serious underlying pathology with red flags.
- Patients having contraindication to physical exercises.
- Females with high parity.
- Pregnant or lactating females.
- Patients who participated in any type of rehabilitative training or exercise program for back pain in last 1 month.
- Spinal deformity or Spinal stenosis.
Show all 14Show fewer
- History of fall or trauma to spine in last one year.
- History of spinal, abdominal or hip surgery.
- Signs of nerve root compression with sensory, motor or deep tendon reflexes deficit.
- Serious underlying pathology with red flags.
- Systemic disease e.g., cardiovascular, metabolic or central nervous system.
- Osteopenia, osteoporosis.
- Medication's history (steroids, immunosuppressants, chemotherapy)
- Limb length discrepancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method of Mechanical Diagnosis & Therapy in Patients With Non-Specific Chronic Low Back Pain
Low back pain (LBP) is the most frequent complaint encountered in clinical practice. Exercises and manual therapy prescription are common physical therapy treatments prescribed for the patients presenting with chronic low back pain. The interventions will establish the future direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research
Read the detailed description
A variety of treatment interventions, modalities and techniques are used in physical therapy management of non-specific low back pain including manual therapy, exercises, neural mobilizations, stretching soft tissue techniques and dry needling etc. Out of these more recent literature supports manual therapy, self exercises, patient counseling and awareness have been recommended in back pain management guidelines, in the United States and is also frequently used in clinical practice in various countries.
Despite multiple theoretical frame works proposing the role of SNAGs and MDT mobilizations and exercises respectively, the literature on the true mechanism of direct or indirect physiological effects of these on performance or performance-related outcomes is vague and lacks justifiable procedural rigor.
The results of this study will provide information regarding the direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research.
- Conditions
- Low Back Pain
- Being tested
- Mulligan Sustained Natural Apophyseal Glide (SNAG), McKenzie Method, Conventional Physical Therapy
- Keywords
- Non-specific Low Back Pain, Sustained Natural Apophyseal Glide, McKenzie Method, Mechanical Diagnosis and Therapy, Range of Motion, Pain, Functional Disability, Fear Avoidance Beliefs
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Sustained Natural Apophyseal Glide (SNAG)Other
Also called Mulligan Mobilization
Application of the MWM technique developed by Brian R. Mulligan. The clinical researcher will perform and holds sustained passive segmental glide at the target joint maintaining the slack whereas the patient will actively move in the direction of pain or stiffness. These MWM techniques when applied to spinal segments or joint is called sustained natural apophyseal glide (SNAG).
McKenzie MethodOther
Also called Mechanical Diagnosis and Therapy (MDT)
An active therapy technique involving repeated movements or sustained positions along with an educational component prescribed to the patient for of minimizing the pain and disability and increase the spinal range of motion. The method will involve the assessment of symptomatic and mechanical responses to repeated movements and sustained positions in the direction of preference. The method will be used for assessment and treatment of patients and with derangement syndrome.
Conventional Physical TherapyOther
It includes usual physical therapy care such as Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy (CPT) Group | Active comparator | Conventional Physical Therapy will consist of Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises. Participants will receive 15 sessions of Conventional Physical Therapy (CPT) at a frequency of 5 sessions per week. Receives: Other: Conventional Physical Therapy |
| Conventional Physical Therapy (CPT) plus Mulligan SNAGs Group | Experimental | Besides Conventional Physical Therapy, Mulligan Mobilizations will be provided in this group. It consist of Extension SNAGS in prone, and Lumbar flexion SNAGS in sitting. The techniques will be applied in 3 sets with 10 repetitions and 60 seconds rest between sets. Receives: Other: Mulligan Sustained Natural Apophyseal Glide (SNAG) |
| Conventional Physical Therapy plus McKenzie MDT Group | Experimental | Along with Conventional Physical Therapy, McKenzie MDT will be be given in this group. It consist of Prone lying, Prone lying Elbow popups, Prone elbow Extension. Standing Extension, supine Both Knee to Chest, Sitting on chair with forward flexion. The techniques will be applied in 3 sets with 8-10 repetitions and 60 seconds rest between sets. Receives: Other: McKenzie Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Level of pain intensity will be measured using Numeric Rating Scale. The 11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Measured: Pain intensity will be recorded as baseline at the time of recruitment and change in pain intensity will be observed at follow up at the end of 3rd week of treatment.
Lumbar Range of Motion
Lumbar Range of motion will be measured using inclinometers. Normal lumbar range of motion include 60 degrees of flexion, 25 degrees of extension, and 25 degrees of lateral bending
Measured: Lumbar Range of Motion will be observed as baseline at the time of recruitment and change in ROM will be observed at follow up at end of 3rd week of treatment.
Level of Functional Disability
Functional Disability will be measured with the Modified Low Back Pain Disability Questionnaire. The scores range from 0-100% with lower scores meaning less disability.
Measured: Functional Disability will be recorded as baseline at the time of recruitment and change in score of functional disability will be recorded at the end of 3rd week of treatment.
Change in Fear Avoidance Beliefs
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Measured: Fear Avoidance Beliefs will be observed as baseline at the time of recruitment and any change in Fear Avoidance Beliefs will be observed at the end of 3rd week of treatment.
Change in Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA)
Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA) will be measured with Rehabilitative Ultrasound Imaging (RUSI).The activation of muscle is represented through change in thickness level of muscle observed through RUSI. The normal thickness of TrA is 3.93mm and LM is 28.99mm.
Measured: The Thickness of muscles will be recorded as baseline at the time of recruitment and change in thickness representing activation will be measured at follow up at the end of 3rd week of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jan 2021
- Primary completion1 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to three study arms and each study arm will be allocated a different intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayesha Jamil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayesha Jamil, University of Lahore
- Investigators
- Prof. Dr Ashfaq Ahmed, PhD, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840666
- Sponsor's protocol ID
- Ahsan Javed
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants data that underlies the results after de-identification
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method of Mechanical Diagnosis & Therapy in Patients With Non-Specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05840666
- Acronym / sponsor ID
- Ahsan Javed
- Conditions
- Low Back Pain
- Keywords
- Non-specific Low Back Pain, Sustained Natural Apophyseal Glide, McKenzie Method, Mechanical Diagnosis and Therapy, Range of Motion, Pain, Functional Disability, Fear Avoidance Beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ayesha JamilUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain (LBP) is the most frequent complaint encountered in clinical practice. Exercises and manual therapy prescription are common physical therapy treatments prescribed for the patients presenting with chronic low back pain. The interventions will establish the future direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research
Detailed description
A variety of treatment interventions, modalities and techniques are used in physical therapy management of non-specific low back pain including manual therapy, exercises, neural mobilizations, stretching soft tissue techniques and dry needling etc. Out of these more recent literature supports manual therapy, self exercises, patient counseling and awareness have been recommended in back pain management guidelines, in the United States and is also frequently used in clinical practice in various countries.
Despite multiple theoretical frame works proposing the role of SNAGs and MDT mobilizations and exercises respectively, the literature on the true mechanism of direct or indirect physiological effects of these on performance or performance-related outcomes is vague and lacks justifiable procedural rigor.
The results of this study will provide information regarding the direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to three study arms and each study arm will be allocated a different intervention
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy (CPT) Group | Active comparator | Other: Conventional Physical TherapyConventional Physical Therapy will consist of Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises. Participants will receive 15 sessions of Conventional Physical Therapy (CPT) at a frequency of 5 sessions per week. |
| Conventional Physical Therapy (CPT) plus Mulligan SNAGs Group | Experimental | Other: Mulligan Sustained Natural Apophyseal Glide (SNAG)Besides Conventional Physical Therapy, Mulligan Mobilizations will be provided in this group. It consist of Extension SNAGS in prone, and Lumbar flexion SNAGS in sitting. The techniques will be applied in 3 sets with 10 repetitions and 60 seconds rest between sets. |
| Conventional Physical Therapy plus McKenzie MDT Group | Experimental | Other: McKenzie MethodAlong with Conventional Physical Therapy, McKenzie MDT will be be given in this group. It consist of Prone lying, Prone lying Elbow popups, Prone elbow Extension. Standing Extension, supine Both Knee to Chest, Sitting on chair with forward flexion. The techniques will be applied in 3 sets with 8-10 repetitions and 60 seconds rest between sets. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of Both genders
- Adult patents between the 20 to 45 years of age with chronic non-specific low back pain.
- Pain intensity of at least 3 or greater on 0-10 Numeric Rating Scale.
- Modified Low Back Pain Disability Questionnaire score equal to or greater than 20%.
Key exclusion criteria (14 listed)
- Serious underlying pathology with red flags.
- Patients having contraindication to physical exercises.
- Females with high parity.
- Pregnant or lactating females.
- Patients who participated in any type of rehabilitative training or exercise program for back pain in last 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan Sustained Natural Apophyseal Glide (SNAG)Also: Mulligan MobilizationApplication of the MWM technique developed by Brian R. Mulligan. The clinical researcher will perform and holds sustained passive segmental glide at the target joint maintaining the slack whereas the patient will actively move in the direction of pain or stiffness. These MWM techniques when applied to spinal segments or joint is called sustained natural apophyseal glide (SNAG). | Other | Conventional Physical Therapy (CPT) plus Mulligan SNAGs Group |
| McKenzie MethodAlso: Mechanical Diagnosis and Therapy (MDT)An active therapy technique involving repeated movements or sustained positions along with an educational component prescribed to the patient for of minimizing the pain and disability and increase the spinal range of motion. The method will involve the assessment of symptomatic and mechanical responses to repeated movements and sustained positions in the direction of preference. The method will be used for assessment and treatment of patients and with derangement syndrome. | Other | Conventional Physical Therapy plus McKenzie MDT Group |
| Conventional Physical TherapyIt includes usual physical therapy care such as Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises. | Other | Conventional Physical Therapy (CPT) Group |
Primary outcome
Pain Intensity
Time frame: Pain intensity will be recorded as baseline at the time of recruitment and change in pain intensity will be observed at follow up at the end of 3rd week of treatment.
Level of pain intensity will be measured using Numeric Rating Scale. The 11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Lumbar Range of Motion
Time frame: Lumbar Range of Motion will be observed as baseline at the time of recruitment and change in ROM will be observed at follow up at end of 3rd week of treatment.
Lumbar Range of motion will be measured using inclinometers. Normal lumbar range of motion include 60 degrees of flexion, 25 degrees of extension, and 25 degrees of lateral bending
Level of Functional Disability
Time frame: Functional Disability will be recorded as baseline at the time of recruitment and change in score of functional disability will be recorded at the end of 3rd week of treatment.
Functional Disability will be measured with the Modified Low Back Pain Disability Questionnaire. The scores range from 0-100% with lower scores meaning less disability.
Change in Fear Avoidance Beliefs
Time frame: Fear Avoidance Beliefs will be observed as baseline at the time of recruitment and any change in Fear Avoidance Beliefs will be observed at the end of 3rd week of treatment.
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Change in Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA)
Time frame: The Thickness of muscles will be recorded as baseline at the time of recruitment and change in thickness representing activation will be measured at follow up at the end of 3rd week of treatment.
Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA) will be measured with Rehabilitative Ultrasound Imaging (RUSI).The activation of muscle is represented through change in thickness level of muscle observed through RUSI. The normal thickness of TrA is 3.93mm and LM is 28.99mm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. Participants data that underlies the results after de-identification
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr Ashfaq Ahmed, PhD study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Sustained Natural Apophyseal Glide (SNAG), McKenzie Method and Conventional Physical Therapy in people with Low Back Pain, run by Ayesha Jamil at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Pain intensity will be recorded as baseline at the time of recruitment and change in pain intensity will be observed at follow up at the end of 3rd week of treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.