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CTRI Number  CTRI/2024/08/072854 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Lumbar Anteroposterior Mobilizations on Pain and Functional Performance on Patients with Anterior Lumbar slippage 
Scientific Title of Study   Effectiveness of Lumbar Anteroposterior Mobilizations on Pain and Functional Performance in Lumbosacral Spondylolisthesis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Suri 
Designation  Physiotherapist 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Cobalt Block, Nehru Hospital, Department of Physical Rehabilitation and Medicine, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7974178011  
Fax    
Email  pginehaphysio@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Neha Suri 
Designation  Physiotherapist 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Cobalt Block, Nehru Hospital, Department of Physical Rehabilitation and Medicine, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7974178011  
Fax    
Email  pginehaphysio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Neha Suri 
Designation  Physiotherapist 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Cobalt block, Nehru Hospital, Department of Physical Rehabilitation and Medicine, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7974178011  
Fax    
Email  pginehaphysio@gmail.com  
 
Source of Monetary or Material Support  
New O.P.D, Department of Physical Rehabilitation and Medicine, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India, Pin code- 160012 
 
Primary Sponsor  
Name  Neha Suri 
Address  PGIMER, Sector 12, Chandigarh, 160012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Neha Suri  Post Graduate Institute of Medical Education and Research  New O.P.D, Department of Physical Rehabilitation and Medicine, sector 12, Chandigarh, India, pin code-160012
Chandigarh
CHANDIGARH 
7974178011

pginehaphysio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Post Graduate Institute of Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M488||Other specified spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stretching Manoeuvers Segmental stabilization Lumbar anteroposterior mobilization   Stretching Manoeuvers: Static stretching of the tight muscles will be performed bilaterally 3-5 times with a 20-30-second hold and 8-10-second rest, depending on muscle stiffness and flexibility level. The hip flexors, hamstrings, and piriformis will be stretched. William’s flexion exercises ten repetitions each; Segmental stabilization- 10 repetitions with 10 sec hold each; Lumbar anteroposterior mobilization- 3-5 sets oscillations maintained for 30-90 sec protocol will be continued for 5 times a week for 4 week with a duration of the session will be 30-35 minutes  
Comparator Agent  Stretching Manoeuvers Segmental stabilization  Stretching Manoeuvers: Static stretching of the tight muscles will be performed bilaterally 3-5 times with a 20-30-second hold and 8-10-second rest, depending on the level of muscle stiffness and flexibility. The hip flexors, hamstrings, and piriformis will be stretched. William’s flexion exercises-10 repetitions each; Segmental stabilization- 10 repetitions with 10 sec hold per session with duration of session will be 30-35 minutes. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients with low back pain due to Lumbosacral spondylolisthesis with or without radiation to the lower limb for more than three months.
2. Patients having tenderness and irregularities in bony alignment, step sign positive
3. Plain Lumbosacral X-rays of forward slippage of L5 over S1 (Anterior/posterior/Lateral/oblique views) demonstrate fracture in pars interarticularis in oblique X-ray; standing lateral X-ray is used to determine the magnitude of forward slip.
 
 
ExclusionCriteria 
Details  1. Recent Trauma
2. LSSL associated with neurological diseases like Guillain-Barre syndrome, Polio, Myasthenia gravis, Cauda equina
3. Bone tumors
4. Severe Rheumatism
5. Severe osteoporosis
6. Associated infections and injuries of the spine, pelvis, and lower limb.
7. Mental health disorders (delirium)
8. Drug abuse
9. Any other complication that could affect their interventions.
10. Patients who had a history of previous lumbar surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale (NPS)
Oswestry disability index questionnaire (ODI)
Rolando Morris disability questionnaire (RMDQ)
Fingertip-to-floor test (in cm)
 
DURATION of the prtocol is 4 weeks. Assessment will be done at baseline, 2nd, and 4th weeks of the physical therapy program. 
 
Secondary Outcome  
Outcome  TimePoints 
Rolando Morris disability questionnaire (RMDQ)
Fingertip-to-floor test (in cm)
 
DURATION of the prtocol is 4 weeks. Assessment will be done at baseline, 2nd, and 4th weeks of the physical therapy program. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Spondylolisthesis has been recognized as one of the pathoanatomical and pathobiomechanical etiologies of low back pain (LBP). The effectiveness and use of various manual therapies are well established in literature in the management of lumbosacral spondylolisthesis, including thoracic mobilization, sacral mobilization, and posteroanterior mobilization of L4 vertebrae, Although anteroposterior mobilizations of L5 are also mentioned in lumbosacral spondylolisthesis, sufficient literature still needs to be provided. This study aims to assess the effectiveness of lumbar anteroposterior mobilizations [LAPMs] in relieving pain and improving functions irrespective of other conservative treatments involving conventional exercises and mobilization among patients with lumbosacral anterolisthesis.

Patients will be recruited from New OPD, Department of Physical Medicine and Rehabilitation, PGIMER Chandigarh. Patients will be thoroughly explained about the study and given a patient information sheet before participation. Then, they will be asked to sign a written informed consent and assent form.   Patient screening will be done as per inclusion and exclusion criteria. All the subjects will undergo a complete musculoskeletal evaluation, and patients will be enrolled as per their eligibility criteria. All the patients will be evaluated for the undermentioned parameters using a numerical pain rating scale, which will be used to assess both lower back and leg pain. Muscle flexibility and range of motion will be evaluated by finger-tip to floor measurements in centimeters, and functional performance will be evaluated using the Modified Oswestry disability index and Roland Morris disability questionnaire.  Patients will be randomly allocated to either of the two groups Interventional group and the Control group. Patients in both groups will be directed to physical therapy five times weekly. The control group will receive conventional physical therapy protocol including stretching manoeuvers for tightened muscles such as the piriformis, hip flexors, hamstring, and thoracolumbar fascia, depending on their level of muscle stiffness, William’s flexion exercises and Lumbar stabilization exercises under our supervision at the physiotherapy section, New OPD, PGIMER Chandigarh. The interventional group will receive lumbar anteroposterior mobilizations followed by conventional physical therapy protocol, including stretching manoeuvers, William’s flexion exercises, and lumbar stabilization exercises under our supervision at the physiotherapy section, New OPD, PGIMER Chandigarh. Both groups will also be advised to use moist heat at home. They will also be advised to follow back care, which includes avoidance of all activities and exercises involving the lumbar spinal extension of the spine. A lumbosacral brace in anti-lordotic posture during traveling and exertion will be recommended. Postural awareness will be given to maintain normal posture. All outcome measurements, Numerical pain rating scale for both lower back and leg pain, muscle flexibility and Range of motion using finger-tip-to-floor distance measurements in centimeters, and functional performance using Oswestry disability index questionnaire, Roland Morris disability questionnaire. This will be noted at baseline, 2nd week of exercise, and 4th week of the physical therapy program.

Statistics: Descriptive data will be calculated as mean and standard deviation. The level of significance of the tests will be considered by p < 0.05 with a 95% confidence interval (CI). The normality of the data will further be determined through the formal tests. Moreover, inter-group comparisons and non-normal cases will be examined via independent T-test and Mann–Whitney U test, respectively. A paired T-test and Wilcoxon signed-rank test will be employed for intra-group comparisons as per the normality of the data.

 

 
 
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