| CTRI Number |
CTRI/2025/09/094019 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Craniosacral Therapy on Heel Pain (Plantar Fasciitis) |
|
Scientific Title of Study
|
Efficacy of Craniosacral Therapy in the management of Plantar Fasciitis: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varun Kalia |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University, Jalandhar - Delhi, Grand Trunk Road, Phagwara.
Jalandhar
PUNJAB
144411
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26576@lpu.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Kalia |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University, Jalandhar - Delhi, Grand Trunk Road, Phagwara.
Jalandhar
PUNJAB
144411
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26576@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Kalia |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University, Jalandhar - Delhi, Grand Trunk Road, Phagwara.
Jalandhar
PUNJAB
144411
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26576@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Lovely Profrofessional University, Jalandhar - Delhi, Grand Trunk Rd, Phagwara, Punjab 144411 |
|
|
Primary Sponsor
|
| Name |
Dr Varun Kalia |
| Address |
Lovely Professional University, Jalandhar Delhi Grand Trunk Road, Phagwara, Punjab, India. 144411 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Riya Singh |
Lovely Professional University, Jalandhar Delhi Grand Trunk Road, Phagwara, Punjab, India. 144411 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suresh Mani |
Physiotherapy Out Patient Department, School of Allied Medical Sciences, Block: 3, Room Number: 105 |
Lovely Professional University, Jalandhar Delhi Grand Trunk Road, Phagwara, Punjab, India. 144411
Kapurthala
PUNJAB |
9878331006
suresh.22315@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Planter fasciitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Craniosacral Therapy along with Conventional Physiotherapy |
This study is designed as a randomized controlled trial (RCT) to evaluate the efficacy of craniosacral therapy (CST) combined with conventional physiotherapy in the management of plantar fasciitis. Individuals clinically diagnosed with plantar fasciitis will be screened for eligibility based on predefined inclusion and exclusion criteria. Prior to enrollment, the study protocol will be explained in detail to all participants, and written informed consent will be obtained. Ethical approval for the trial has already been secured from the Institutional Ethical Committee of Lovely Professional University. Eligible participants will then be randomly allocated into two groups using a computer-generated randomization schedule.
Participants in Group A will receive a combination of craniosacral therapy and conventional physiotherapy. During the intervention, subjects will be positioned comfortably in a supine position on a therapy table in a quiet and controlled environment to ensure relaxation and minimize external distractions. A certified physiotherapist trained in CST will perform gentle, light-touch manual techniques to assess and optimize the craniosacral system. Specific treatment regions will include the sacrum, where mobilization techniques will be used to target fascial continuity and myofascial connections with the plantar fascia; the occipital and temporal bones, where applied techniques will facilitate parasympathetic dominance and reduce sympathetic overactivity; and the superficial back line (SBL), where fascial palpation and soft tissue release will be carried out to alleviate tension along the posterior kinetic chain influencing the plantar fascia. Each CST session will last for 40–45 minutes and will be delivered three times per week over two consecutive weeks, amounting to a total of six sessions.
Immediately following CST, participants will undergo stretching exercises targeting the plantar fascia and calf muscles, strengthening exercises for intrinsic foot muscles and ankle stabilizers, ultrasound therapy as per the institution’s standard protocol, and patient education regarding footwear modification and activity management.
Outcome measures will be assessed at two time points: baseline (pre-intervention) and after completion of the two-week intervention program (post-intervention). Pain intensity will be measured using the Visual Analogue Scale (VAS), while foot functionality will be evaluated through the Foot Function Index (FFI). Ankle range of motion (ROM) will be assessed using a universal goniometer, and muscle strength of the tibialis anterior as well as the gastrocnemius–soleus complex will be graded using Manual Muscle Testing (MMT). |
| Comparator Agent |
Group B:Conventional Physiotherapy |
Participants assigned to Group B will receive only conventional physiotherapy interventions specifically designed for plantar fasciitis.
Stretching Exercises: Participants will perform static stretches targeting the plantar fascia and calf muscles. The plantar fascia stretch will be performed in a seated position by dorsiflexing the ankle and extending the toes using the opposite hand, holding the stretch for 20–30 seconds, repeated three times per session. The calf muscle stretch (gastrocnemius and soleus) will be carried out in a standing position against a wall, held for 30 seconds and repeated three times for each leg. Stretching exercises will be performed once daily as part of the supervised sessions and reinforced with home exercise instructions.
Strengthening Exercises: Strengthening will focus on the intrinsic foot muscles and ankle stabilizers. Participants will be asked to perform towel curl exercises (gripping and pulling a towel using the toes) and marble pick-up exercises, both repeated for 10–12 repetitions in two sets. In addition, resisted ankle inversion and eversion using therabands will be performed for 10 repetitions in two sets. Strengthening exercises will be performed three times per week under supervision and continued at home once daily with therapist guidance.
Ultrasound Therapy: Therapeutic ultrasound will be administered to the plantar fascia region using a frequency of 1 MHz, intensity of 1.5 W/cm², and continuous mode. The treatment head will be moved in slow circular motions over the affected area for 5–7 minutes. Ultrasound therapy will be provided three times per week throughout the two-week intervention period.
The total session duration for Group B will be approximately 40–45 minutes, conducted three times per week for two consecutive weeks, amounting to six supervised sessions in total.
Outcome Measures: Same as the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Adults above 18 years of age diagnosed with plantar fasciitis.
Duration of heel pain more than 3 months.
Positive Windlass test or pain reproduced on passive toe extension.
Tenderness along the plantar fascia on palpation.
Reduced ankle mobility.
Not undergoing any current physiotherapy or other treatment for plantar fasciitis. |
|
| ExclusionCriteria |
| Details |
Current undergoing physiotherapy treatment for plantar fasciitis.
Use of medications such as NSAIDs or analgesics for heel pain within the last 2 weeks.
Patients already performing self-massage, stretching, or home-based exercises for plantar fascia.
Past history of stroke, recent head injury, skull fractures, aneurysm, or other contraindications to Craniosacral Therapy (CST).
Patients currently undergoing Craniosacral Therapy or similar manual therapy interventions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale (VAS) for the pain assessment.
Universal Goniometer for the Range of motion assessment of ankle joint. |
Pretest (Before starting the tretment protocol at 0 day) and Post test (After the complition of tretment protocol at 12th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot Function Index to check the functional disability. |
Pretest (Before starting the tretment protocol at 0 day) and Post test (After the complition of tretment protocol at 12th day) |
| Manual Muscle Testing to check the muscle strength |
Pretest (Before starting the tretment protocol at 0 day) and Post test (After the complition of tretment protocol at 12th day) |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [varun.26576@lpu.co.in].
- For how long will this data be available start date provided 30-09-2025 and end date provided 31-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Plantar fasciitis is one of the most common causes of heel pain, often resulting in functional limitations and reduced quality of life. Conventional physiotherapy, including stretching, strengthening, ultrasound therapy, and patient education, has been widely used in its management. Craniosacral therapy (CST) is a gentle manual therapy technique that aims to release fascial restrictions and restore balance in the craniosacral system, which may influence musculoskeletal structures through fascial and neural connections. However, its role in plantar fasciitis management remains underexplored.
The present randomized controlled trial is designed to evaluate the efficacy of craniosacral therapy in addition to conventional physiotherapy compared to conventional physiotherapy alone. Individuals clinically diagnosed with plantar fasciitis will be screened based on inclusion and exclusion criteria. Eligible participants will provide informed consent and will then be randomly allocated into two groups using a computer-generated randomization method.
Group A will receive CST along with conventional physiotherapy, while Group B will receive only conventional physiotherapy. Each intervention session will last 40–45 minutes and will be conducted three times per week for two consecutive weeks, totaling six sessions.
Outcome measures will be assessed at baseline and after two weeks. These will include pain intensity (Visual Analogue Scale), foot function (Foot Function Index), ankle range of motion (goniometer), and muscle strength of tibialis anterior and gastrocnemius–soleus (Manual Muscle Testing). All assessments will be carried out by a blinded assessor.
This trial will help determine whether craniosacral therapy provides additional benefit over conventional physiotherapy in reducing pain and improving functional outcomes in individuals with plantar fasciitis. |