| 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
|
|
|
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
|
|
|
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.
|