| CTRI Number |
CTRI/2025/04/085636 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of ultrasound and long wave treatment for adult plantar fasciitis |
|
Scientific Title of Study
|
Comparison between Long wave therapy and Ultrasound therapy in plantar Fasciitis among adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farman Ahmad |
| Designation |
Undergraduate |
| Affiliation |
Galgotias university |
| Address |
B-319,B-block,Department of Physiotherapy, Galgotias University, Greater Noida, Uttar Pradesh,203201,India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7631393843 |
| Fax |
|
| Email |
ffarman836@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias university |
| Address |
Room No B-319,Department of Physiotherapy,Galgotias University,Plot No 2,Sector 17A,Opposite Buddha
International Circuit,Greater Noida,Gautam Buddha Nagar,Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8447767591 |
| Fax |
|
| Email |
narendrakumargims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farman Ahmad |
| Designation |
Undergraduate |
| Affiliation |
Galgotias university |
| Address |
B-319,B-block,Department of Physiotherapy, Galgotias University, Greater Noida, Uttar Pradesh,203201,India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7631393843 |
| Fax |
|
| Email |
ffarman836@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
School of Allied Health Sciences Department of Physiotherapy,Gautam Buddha Nagar,Gautam Buddha Nagar 203201,India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Narendra Kumar |
Galgotias University |
Room No B-319,Department of Physiotherapy,Galgotias University,Plot No 2,Sector 17A,Opposite Buddha International Circuit,Greater Noida,Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
8447767591
narendrakumargims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults diagnosed with plantar Fasciitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Longwave Therapy |
Group 1 will receive longwave therapy, a form of deep tissue electromagnetic treatment.The therapy sessions will be conducted five times a week for four weeks, with each session lasting approximately 20 minutes.The longwave therapy device will be set to deliver electromagnetic waves at a frequency of 1–30 MHz, targeting the affected heel area for 4 weeks |
| Comparator Agent |
Ultrasound Therapy |
Group 2 will receive ultrasound therapy,a widely used physiotherapeutic intervention for soft tissue injuries.The treatment will also be administered five times a week for four weeks, with each session lasting approximately 15 minutes.The ultrasound device will be set to a frequency of 1–3 MHz, depending on the depth of tissue being targeted,with an intensity of 0.8 to 1.2 W/cm². The ultrasound head will be applied to the affected heel area using a coupling gel to ensure effective transmission of sound waves for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals aged 25-50 years.
2 Diagnosed with plantar fasciitis for at least 3 months.
3 Moderate to severe heel pain.
4 Willingness to participate and comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
1 Previous surgery on the affected foot.
2 Presence of systemic inflammatory conditions (e.g., rheumatoid arthritis).
3 Pregnancy or lactation.
4 Use of corticosteroid injections in the past 3 months.
5 Neurological disorders affecting lower limbs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the effectiveness of longwave therapy and ultrasound therapy in the treatment of plantar fasciitis |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the effectiveness of longwave therapy and ultrasound therapy in the treatment with a focus on pain reduction, functional improvement, and overall quality of life. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/05/2025 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 26-10-2025 and end date provided 08-11-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Plantar fasciitis is the most common cause of heel pain, striking a significant percentage of the population who are physically active or whose jobs demand standing for extended periods(1). It is an inflammatory and microscopic tearing of the plantar fascia thick band of tissue running along the bottom of the foot from the heel bone out to the toes. This condition is frequently precipitated by the stabbing pain felt from the first steps of the day or after extended periods of inactivity. Longwave therapy, or longwave diathermy, is an electrotherapy modality that has the form of electromagnetic waves between 1–30 MHz. The treatment penetrates the body quite deeply and produces heat, promoting physiological change at a cellular level. The principle for the action of longwave therapy is the induction of electromagnetic fields causing ionic movement in the tissues, that means greater tissue temperature, increased blood flow, and increased cellular metabolism. This induces the thermal response of the body and relaxes spasms in the muscles with pain relief due to the healing of soft tissues(8,9).Longwave therapy, being a deep-penetrating modality, helps in conditions where greater penetration is needed to treat the inflammation and pain caused by the plantar fascia, such as in plantar fasciitis. Ultrasound therapy is one of the most ancient physiotherapeutic interventions that have been established, wherein high-frequency sound waves with frequencies ranging from 1–3 MHz are administered to treat soft tissue injuries. It brings about thermal and non-thermal effects by raising tissue temperature as ultrasound energy is absorbed by tissues. Rise in tissue temperature by heat promotes vasodilation, better flow of blood, and decreases muscle stiffness; thus, pain may be significantly relieved and the elasticity of the plantar fascia may improve. This comparative study will be helpful in understanding the best therapeutic approach for this debilitating condition and hence aid clinicians in making evidence-based decisions in management. |