NCT06556823

Brief Summary

The aim of this randomized clinical trial is to find the comparison of CLNDT and SMWLM technique in diabetic and non-diabetic sciatica patients on reducing back pain and improving range of motion of knee

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

August 13, 2024

Last Update Submit

February 20, 2025

Conditions

Keywords

Contralateral leg neuro-dynamic technique,Spine mobilization with leg movementSciatica due to lumbar degenerative problems

Outcome Measures

Primary Outcomes (3)

  • Goniometer

    It is a tool used to measure the range of motion of joint (0-180). Positioning plays a vital part in goniometry because it helps to place the joints in a zero starting or neutral position. The examiner stabilizes the proximal joint component and then carefully moves the distal component of the joint through its entire available range of motion until reaching the end feel. By using universal goniometer ROM of knee will be assessed, patient will be in supine lying with both legs on the table, fulcrum of goniometer will be aligned with lateral epicondyle while stationary arm is in align with lateral epicondyle and midline of femur. While moving arm is with lateral malleolus and fibula border, while maintaining same position flexion and extension will be performing and measure.

    three weeks

  • Numeric Pain Rating Scale

    The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain.

    three weeks

  • Modified Oswestry low back pain Disability Index

    The Modified Oswestry Low back pain disability index is widely used standardized questionnaires used by health professional to evaluate patient disability level in patient with low back pain that how patients low back pain affect daily life activities. ODI consists of 10 different questions each score range from 0-5 from minimum to maximum. The score of each section is summed and then divided into total and multiply by 100.

    three weeks

Study Arms (4)

Contralateral Leg Neuro Dynamic+ Conventional PT in Diabetic Population):

EXPERIMENTAL

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Other: CLNDT+ Conventional PT in Diabetic Population):

contralateral Leg Neuro Dynamic+ Conventional PT in non Diabetic Population):

EXPERIMENTAL

The patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set.

Other: CLNDT+ Conventional PT in non Diabetic Population):

Spine Mobilization With Leg Movement+ Conventional PT in Diabetic Population)

EXPERIMENTAL

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set)

Other: SMWLM+ Conventional PT in Diabetic Population)

Spine Mobilization With Leg Movement+ Conventional PT in non Diabetic Population)

EXPERIMENTAL

The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec.

Other: SMWLM+ Conventional PT in non Diabetic Population)

Interventions

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Contralateral Leg Neuro Dynamic+ Conventional PT in Diabetic Population):

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

contralateral Leg Neuro Dynamic+ Conventional PT in non Diabetic Population):

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Spine Mobilization With Leg Movement+ Conventional PT in Diabetic Population)

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Spine Mobilization With Leg Movement+ Conventional PT in non Diabetic Population)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having sciatica due to degenerative lumbar spine disorder confirm by Straight leg Rise test and Slump test.
  • Patients having unilateral radiating leg pain
  • Type 2 Diabetic population with past 3 years' history of Diabetes with HbA1c value 5.7% or above

You may not qualify if:

  • Subject having bilateral leg pain or Cauda equina syndrome
  • History of fracture at lumbar spine
  • Patient having history of lumbar spine surgery or in symptomatic leg
  • Subject having lower extremity vascular disease, Malignancy and pregnant female
  • Participant having steroid therapy with in last 6 months.
  • Subject having Hip pathologies like hip OA, tendinitis and Bursitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 16, 2024

Study Start

July 3, 2024

Primary Completion

December 2, 2024

Study Completion

January 10, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations