Protocol summary

Study aim
To investigate whether adding active neuromuscular electrical stimulation to core-pelvic stability training produces greater improvement in lumbar lordosis angle compared to exercise alone or exercise plus sham NMES.
Design
A three-arm parallel-group will randomize controlled trial with assessor blinding and a pretest-posttest design. Participants will be allocated in a 1:1:1 ratio to one of three groups (Exercise, Exercise + Sham NMES, Exercise + Active NMES). The randomization sequence will generate using permuted blocks of six by an independent biostatistician, and group allocation will be concealed using sequentially numbered opaque sealed envelopes (SNOSE). Outcome assessors and the statistician will be blinded to group allocation.
Settings and conduct
The study will conducted in Isfahan, Iran. All intervention sessions (exercise and electrical stimulation) will delivered in-person under direct supervision. Baseline and post-intervention assessments will be also will perform at the same center by a trained examiner who will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Women aged 25–40 years Lumbar lordosis >45° (measured by flexible ruler) Anterior pelvic tilt >12° (measured by digital inclinometer) History of spinal surgery or fracture Acute or chronic low back pain requiring treatment within the past year Neurological or vestibular disorders affecting balance Pregnancy or delivery within the previous 12 months Musculoskeletal deformities (congenital or acquired) Participation in structured core stability training within the previous 6 months Contraindications to NMES (e.g., pacemaker, epilepsy, skin conditions at electrode sites) Inability to attend scheduled sessions
Intervention groups
3gruops: Exercise Sham NMES Active NMES
Main outcome variables
Lumbar Lordosis Angle

General information

Reason for update
Acronym
NMES-Lordosis Trial
IRCT registration information
IRCT registration number: IRCT20211103052956N2
Registration date: 2026-08-10, 1405/05/19
Registration timing: registered_while_recruiting

Last update: 2026-08-10, 1405/05/19
Update count: 0
Registration date
2026-08-10, 1405/05/19
Registrant information
Name
Saeid Rostami
Name of organization / entity
Ragheb Isfahani higher education institute
Country
Iran (Islamic Republic of)
Phone
+98 31 3368 9040
Email address
srostami.20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2026-05-10, 1405/02/20
Actual recruitment start date
2026-04-21, 1405/02/01
Actual recruitment end date
2026-08-11, 1405/05/20
Trial completion date
2026-10-23, 1405/08/01
Scientific title
Additive Effects of Active Versus Sham Neuromuscular Electrical Stimulation Added to Core-Pelvic Stability Training in Women with Lumbar Hyperlordosis and Anterior Pelvic Tilt: A Randomized Controlled Trial
Public title
Effects of Electrical Stimulation on Lumbar Lordosis and Pelvic Tilt in Women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 25–40 yearsLumbar lordosis >45° (measured by flexible ruler)Anterior pelvic tilt >12° (measured by digital inclinometer)
Exclusion criteria:
History of spinal surgery or fracture, Acute or chronic low back pain requiring treatment within the past year, Neurological or vestibular disorders affecting balance, Pregnancy or delivery within the previous 12 months, Musculoskeletal deformities (congenital or acquired), Participation in structured core stability training within the previous 6 months, Contraindications to NMES (e.g., pacemaker, epilepsy, skin conditions at electrode sites), Inability to attend scheduled sessions
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 87
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using permuted blocks of six with a 1:1:1 allocation ratio. The random sequence was generated by an independent biostatistician, and group allocation was concealed using sequentially numbered opaque sealed envelopes (SNOSE).
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessors and statisticians were blinded to group allocation. Participants and trainers could not be blinded due to the exercise-based nature of the intervention, but participants were instructed not to disclose their group assignment during testing sessions.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of reserches (Islamic Azad university, Isfahan branch)
Street address
Arghavanie street
City
isfahan
Province
Isfehan
Postal code
8316111258
Approval date
2026-02-08, 1404/11/19
Ethics committee reference number
IR.KHUISF.REC.1403.260

Health conditions studied

1

Description of health condition studied
hyperlordosis
ICD-10 code
M40.4
ICD-10 code description
Postural lordosis

Primary outcomes

1

Description
Variable name: Lumbar Lordosis Angle,Unit of measurement: Degrees (°)
Timepoint
The mean of three consecutive measurements will recorded. Timing of measurement: Before the start of the intervention (baseline) and immediately after the 8-week intervention period (post-intervention)
Method of measurement
Measurement method: Measured using a flexible ruler (non-elastic tape) will place along the spinous processes from T12 to S2 in a relaxed standing position. The lordotic angle will calculate using the formula: angle (degrees) = 4 × (arc height / chord length) × 57.3.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: exercise
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Street address
Basij
City
Isfahan
Province
Isfehan
Postal code
8116532574
Phone
+98 31 3368 7040
Email
srostami.20@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Street address
Bassij
City
Isfahan
Province
Isfehan
Postal code
8116237458
Phone
+98 31 3368 7040
Email
srostami.20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ragheb Isfahani higher education institute
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Position
Assistan professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Bassij
City
Isfahan
Province
Isfehan
Postal code
8136478549
Phone
0098313687040
Email
srostami.20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Bassij
City
isfahan
Province
Isfehan
Postal code
84164835498
Phone
0098313687040
Email
srostami.20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ragheb Isfahani higher education institute
Full name of responsible person
Saeid Rostami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Bassij
City
Isfahan
Province
Isfehan
Postal code
8136445698
Phone
000098313687040
Email
srostami.20@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
De-identified individual participant data (IPD): Includes demographic data (age, height, weight, BMI), primary outcome data (lumbar lordosis angle at two time points), secondary outcome data (anterior pelvic tilt angle and plank endurance time at two time points), and group allocation data. All data will be shared after removing identifiable information (names, surnames, contact numbers, and addresses).
When the data will become available and for how long
Access Start: 6 months after publication of the study results in a peer-reviewed scientific journal. Access End: Up to 5 years after publication of results (in accordance with ICMJE standards). Estimated Publication Date: Within 12 months after study completion (study completion: 8 weeks after last participant enrollment).
To whom data/document is available
Researchers affiliated with academic and scientific institutions who submit a written request and obtain approval from their institutional ethics committee. Also, researchers intending to conduct secondary analyses or meta-analyses for scientific and non-commercial purposes. Additional conditions: Priority will be given to researchers who have an approved research proposal from their institutional ethics committee and sign a non-disclosure agreement committing to use the data solely for scientific purposes.
Under which criteria data/document could be used
Data and documents may be used exclusively for scientific and research purposes. Permitted uses include: Secondary analyses for research purposes Meta-analyses and systematic reviews Validation of the original study results Education and research methodology training Conditions of use: Proper citation of the original article is mandatory Commercial or for-profit use is prohibited Any new publication of results must be coordinated with the responsible authors Data must not be transferred to third parties
From where data/document is obtainable
Name: Dr. Saeid Rostami (Corresponding Author and General Public Contact Person) Email: srostami.20@gmail.com Phone: 00989131088601 Postal Address: Department of Sport Sciences, Faculty of Human Sciences, Ragheb Isfahani Higher Education Institute, Isfahan, Iran. Postal Code: 81551-39998 Initial Contact Method: Submit a written request via email, including the study title, IRCT registration code, and proposed research plan for data analysis.
What processes are involved for a request to access data/document
Request Process Steps: Submit a written request via email to the corresponding author (including: study title, IRCT code, requester's full details, institutional affiliation, and purpose of data use) Initial review by the research team (maximum 2 weeks) If approved: Send the non-disclosure agreement and data use agreement form for signature Receive signed form and final approval from the requester's institutional ethics committee Send data/documents via email or secure download link (maximum 4 weeks after final approval) Total Process Time: Approximately 4 to 6 weeks from receipt of a complete request
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